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The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.
Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.
This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice.
This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort.
The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit.
This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD Participants With CPF | Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning. | At inclusion visit (Day 1) |
| Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12]) | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning. | At inclusion visit (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL. |
Not provided
Inclusion Criteria:
Diagnosed with CD.
Presence of CPF(s), defined as >=1 of the following criteria:
Attending routine gastroenterology appointments at the participating hospitals.
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants diagnosed with CD and CPFs in the Portuguese routine clinical practice will be assessed.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar e Universitario de Coimbra (CHUC) | Coimbra | 3000-075 | Portugal | |||
| Centro Hospitalar Universitario de Lisboa Central (CHULC) |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Crohn's disease (CD) with complex perianal fistulas (CPF) were enrolled from the investigative sites' database and were observed in a cross-sectional way along with a retrospective component to collect data for healthcare resource utilization and on the pharmacological and surgical treatments in this study.
Data from participants were collected for this cross-sectional, observational study with a retrospective component at two investigative sites in Portugal from 9 July 2021 to 27 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD Participants With CPF | Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CD Participants With CPF | Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12] | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning. | All eligible participants with CD and CPAF were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
Up to 10 months 18 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD Participants With CPF | Participants diagnosed with CD and CPF in the Portuguese routine clinical practice were assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years was obtained from the medical records. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2021 | May 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2022 | May 18, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| At inclusion visit (Day 1) |
| Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants | SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life. | At inclusion visit (Day 1) |
| Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants | SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life. | At inclusion visit (Day 1) |
| Fecal Incontinence as Assessed by Wexner Score | Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence. | At inclusion visit (Day 1) |
| Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% representing no impact on productivity and 100% representing complete impact on productivity. Higher scores indicate greater impairment. | At inclusion visit (Day 1) |
| Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to [>=] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported. | Up to 3 years prior to the inclusion visit at Day 1 |
| Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI). | At inclusion visit (Day 1) |
| Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae. | At inclusion visit (Day 1) |
| Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category. | Up to 3 years prior to the inclusion visit at Day 1 |
| Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. | At inclusion visit (Day 1) |
| Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. MCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. | At inclusion visit (Day 1) |
| Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, Perianal Disease Activity Index (PDAI) score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. | At inclusion visit (Day 1) |
| Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, PDAI score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. | At inclusion visit (Day 1) |
| Lisbon |
| 1169-050 |
| Portugal |
| Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM) | Lisbon | 1649-028 | Portugal |
| Centro Hospitalar Universitario de Sao Joao (CHUSJ) | Porto | 4200-319 | Portugal |
| Centro Hospitalar Tondela-Viseu (CHTV) | Viseu | 3504-509 | Portugal |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | BMI=Weight (kg)/Height (meter)^2 | Mean | Standard Deviation | kg/meter^2 |
|
|
|
| Primary | Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12]) | SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning. | All eligible participants with CD and CPAF were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is an instrument used to assess QoL and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score is reported and ranges from 10 to 70 with a higher score indicating a better health-related QoL. | All eligible participants with CD and CPAF were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants | SQOL-M assessed the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best), completely agree = 1 to completely disagree = 6. The total score can range from 11 to 66 points. Higher scores indicate better male sexual quality of life. | All eligible male participants with CD and CPAF were included in the analysis and are presented as the overall number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants | SQOL-F assessed the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life. | All eligible female participants with CD and CPAF with data available for analyses were included and are presented as the overall number of participants analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Fecal Incontinence as Assessed by Wexner Score | Fecal incontinence is measured by Wexner score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that ranges from 0 to 20. Higher scores indicate worse fecal incontinence. | All eligible participants with CD and CPAF were included in the analysis. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score | WPAI score was used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assesses the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment / disability. Scores are presented as percentages (multiplying the scores by 100), Domain scores are expressed as a percentage, with a range of scores form 0-100%, with 0% representing no impact on productivity and 100% representing complete impact on productivity. Higher scores indicate greater impairment. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
| Secondary | Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years | Number of participants characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit were collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to [>=] 24 hours) due to CPF, and intensive care unit (ICU) admission. Only categories with at least one participant with event are reported. | All eligible participants with CD and CPAF were included in the analysis. | Posted | Count of Participants | Participants | Up to 3 years prior to the inclusion visit at Day 1 |
|
|
|
| Secondary | Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics | Sociodemographic and anthropometric variables included age (in years), sex (male or female), and body mass index (BMI). | All eligible participants with CD and CPAF were included in the analysis. | Posted | Count of Participants | Participants | At inclusion visit (Day 1) |
|
|
|
| Secondary | Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics | The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae. | All eligible participants with CD and CPAF were included in the analysis. | Posted | Count of Participants | Participants | At inclusion visit (Day 1) |
|
|
|
| Secondary | Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF | For each pharmacological treatment (antibiotics, monoclonal antibodies, immunosuppressants, and others), participants were divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit. Surgical treatment in the last three years for the management of CPF was also recorded. A participant may be included in more than one category. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Count of Participants | Participants | Up to 3 years prior to the inclusion visit at Day 1 |
|
|
|
| Secondary | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. PCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
|
| Secondary | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables | The following qualitative variables were considered for the bivariate analysis: sex, smoking status, employment status, extraintestinal manifestations of Crohn's disease, Montreal classification for CD disease (age at onset, disease location, and disease behavior), fistula type and position, CD disease activity, treatment-naïve, surgery-naïve, type of surgery, and presence of seton, perianal abscess and anorectal stricture. MCS-12 scores were transformed to a 0 to 100, with higher scores indicating better quality of life. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Mean | Standard Deviation | score on a scale | At inclusion visit (Day 1) |
|
|
|
|
| Secondary | Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, Perianal Disease Activity Index (PDAI) score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Number | correlation coefficient | At inclusion visit (Day 1) |
|
|
|
|
| Secondary | Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables | The following quantitative variables were considered for bivariate analysis: age, BMI, time between CD diagnosis date and date of study visit, total number of CPFs per participant, time between first CPF diagnosis date and date of study visit, PDAI score, number of internal and external fistula openings, time since seton placement, SIBDQ score, SQoL-M score (for male participants) and SQoL-F score (for female participants), and Wexner score. Data was collected and reported as number for all the quantitative variables as the associations (correlation coefficient) between general QoL and the quantitative variables was calculated using Spearman Correlation Coefficients. | All eligible participants with CD and CPAF were included in the analysis. Number analyzed is the number of participants with data available for analysis in the specified category. | Posted | Number | correlation coefficient | At inclusion visit (Day 1) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D007410 | Intestinal Diseases |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Work Productivity Loss |
|
|
| Activity Impairment |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| BMI: Underweight |
|
| BMI: Normal range |
|
| BMI: Overweight |
|
| BMI: Obese |
|
| Title | Measurements |
|---|---|
|
| Disease Location 3: Ileocolon |
|
| Disease Location 3 + 4: Ileocolon + Upper Gastrointestinal |
|
| Disease Behavior, Perianal Disease B1p: Nonstricturing, Nonpenetrating + Perianal |
|
| Disease Behavior, Perianal Disease B2p: Stricturing + Perianal |
|
| Disease Behavior, Perianal Disease B3p: Penetrating + Perianal |
|
|
| Current Users: Immunosuppressants |
|
|
| Past Users: Antibiotics |
|
|
| Past Users: Monoclonal Antibodies |
|
|
| Past Users: Immunosuppressants |
|
|
| Non-users: Antibiotics |
|
|
| Non-users: Monoclonal Antibodies |
|
|
| Non-users: Immunosuppressants |
|
|
| Non-users: Others |
|
|
| Surgical Treatment in the Last Three Years for the Management of CPF- Yes |
|
|
| Surgical Treatment in the Last Three Years for the Management of CPF- No |
|
|
|
| PCS-12: Employment Status- Employed |
|
|
| PCS-12: Employment Status- Unemployed |
|
|
| PCS-12: Employment Status- Retired |
|
|
| PCS-12: Employment Status- Student |
|
|
| PCS-12: Employment Status- Other |
|
| PCS-12: Smoking Status- Never |
|
|
| PCS-12: Smoking Status- Former |
|
|
| PCS-12: Smoking Status- Current |
|
|
| PCS-12: Age at Onset of CD Diagnosis - At or Below 16 Years |
|
|
| PCS-12: Age at Onset of CD Diagnosis - Between 17 and 40 Years |
|
|
| PCS-12: Age at Onset of CD Diagnosis - Above 40 Years |
|
|
| PCS-12: Disease Location 1- Terminal Ileum |
|
|
| PCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal |
|
|
| PCS-12: Disease Location 2- Colon |
|
|
| PCS-12: Disease Location 2 + 4- Colon + Upper Gastrointestinal |
|
| PCS-12: Disease Location 3- Ileocolon |
|
|
| PCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal |
|
|
| PCS-12: Disease Location 4- Upper Gastrointestinal |
|
| PCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal |
|
|
| PCS-12: Disease Behavior- Stricturing + Perianal |
|
|
| PCS-12: Disease Behavior- Penetrating + Perianal |
|
|
| PCS-12: Extraintestinal Manifestation of CD- Yes |
|
|
| PCS-12: Extraintestinal Manifestation of CD- No |
|
|
| PCS-12: Fistula With High Intersphincteric Type- Yes |
|
|
| PCS-12: Fistula With High Intersphincteric Type- No |
|
|
| PCS-12: Fistula With High Transsphincteric Type- Yes |
|
|
| PCS-12: Fistula With High Transsphincteric Type- No |
|
|
| PCS-12: Fistula With Suprasphincteric Type- Yes |
|
|
| PCS-12: Fistula With Suprasphincteric Type- No |
|
|
| PCS-12: Fistula With Extrasphincteric Type- Yes |
|
|
| PCS-12: Fistula With Extrasphincteric Type- No |
|
|
| PCS-12: Fistula With Superficial Type- Yes |
|
| PCS-12: Fistula With Superficial Type- No |
|
|
| PCS-12: Fistula With Low Intersphincteric Type- Yes |
|
|
| PCS-12: Fistula With Low Intersphincteric Type- No |
|
|
| PCS-12: Fistula With Low Transsphincteric Type- Yes |
|
|
| PCS-12: Fistula With Low Transsphincteric Type- No |
|
|
| PCS-12: Fistula With Midline Position- Yes |
|
|
| PCS-12: Fistula With Midline Position- No |
|
|
| PCS-12: Fistula With Lateral Position- Yes |
|
|
| PCS-12: Fistula With Lateral Position- No |
|
|
| PCS-12: Fistula With Seton- Yes |
|
|
| PCS-12: Fistula With Seton- No |
|
|
| PCS-12: Harvey-Bradshaw Index (HBI) Category- Remission |
|
|
| PCS-12: HBI Category- Mild Activity |
|
|
| PCS-12: HBI Category- Moderate Activity |
|
|
| PCS-12: HBI Category- Severe Activity |
|
| PCS-12: Treatment-naïve- Yes |
|
|
| PCS-12: Treatment-naïve- No |
|
|
| PCS-12: Surgery-naïve- Yes |
|
|
| PCS-12: Surgery-naïve- No |
|
|
| PCS-12: Surgery - Fistulotomy- Yes |
|
|
| PCS-12: Surgery - Fistulotomy- No |
|
|
| PCS-12: Surgery - Advancement Flap- Yes |
|
| PCS-12: Surgery - Advancement Flap- No |
|
|
| PCS-12: Surgery - Ligation of the Intersphincteric Fistula Tract (LIFT)- Yes |
|
| PCS-12: Surgery - LIFT- No |
|
|
| PCS-12: Surgery - Fibrin Glue- Yes |
|
| PCS-12: Surgery - Fibrin Glue- No |
|
|
| PCS-12: Surgery - Anal Fistula Plug- Yes |
|
| PCS-12: Surgery - Anal Fistula Plug- No |
|
|
| PCS-12: Surgery - Defunctioning Stoma- Yes |
|
| PCS-12: Surgery - Defunctioning Stoma- No |
|
|
| PCS-12: Surgery - Cutting Seton- Yes |
|
| PCS-12: Surgery - Cutting Seton- No |
|
|
| PCS-12: Surgery - Loose Seton- Yes |
|
|
| PCS-12: Surgery - Loose Seton- No |
|
|
| PCS-12: Surgery - Other- Yes |
|
|
| PCS-12: Surgery - Other- No |
|
|
| PCS-12: Presence of Perianal Abscess- Yes |
|
|
| PCS-12: Presence of Perianal Abscess- No |
|
|
| PCS-12: Presence of Anorectal Stricture- Yes |
|
| PCS-12: Presence of Anorectal Stricture- No |
|
|
| =0.8241 |
| Superiority |
| PCS-12: Smoking Status | ANOVA | =0.3471 | Superiority |
| PCS-12: Age at Onset | ANOVA | =0.9951 | Superiority |
| PCS-12: Disease Location | ANOVA | =0.0631 | Superiority |
| PCS-12: Disease Behavior | ANOVA | =0.7473 | Superiority |
| PCS-12: Presence of any Extraintestinal Manifestation of CD | t-test for Independent Samples | =0.4422 | Superiority |
| PCS-12: Fistula With High Intersphincteric Type | t-test for Independent Samples | =0.1796 | Superiority |
| PCS-12: Fistula With High Transsphincteric Type | t-test for Independent Samples | =0.3535 | Superiority |
| PCS-12: Fistula With Suprasphincteric Type | t-test for Independent Samples | =0.1508 | Superiority |
| PCS-12: Fistula with Extrasphincteric Type | t-test for Independent Samples | =0.2671 | Superiority |
| PCS-12: Fistula With Low Intersphincteric Type | t-test for Independent Samples | =0.0594 | Superiority |
| PCS-12: Fistula With Low Transsphincteric Type | t-test for Independent Samples | =0.5484 | Superiority |
| PCS-12: Fistula With Midline Position | t-test for Independent Samples | =0.5387 | Superiority |
| PCS-12: Fistula With Lateral Position | t-test for Independent Samples | =0.5270 | Superiority |
| PCS-12: Fistula With Seton | t-test for Independent Samples | =0.3863 | Superiority |
| PCS-12: HBI Categories (Remission, Mild and Moderate Activity) | ANOVA | =0.4206 | Superiority |
| PCS-12: Surgery-naïve | t-test for Independent Samples | =0.0538 | Superiority |
| PCS-12: Surgery - Fistulotomy | t-test for Independent Samples | =0.9572 | Superiority |
| PCS-12: Surgery - Loose Seton | t-test for Independent Samples | =0.4742 | Superiority |
| PCS-12: Surgery - Other | t-test for Independent Samples | =0.5735 | Superiority |
| PCS-12: Presence of Perianal Abscess | t-test for Independent Samples | =0.3760 | Superiority |
|
| MCS-12: Employment Status- Employed |
|
|
| MCS-12: Employment Status- Unemployed |
|
|
| MCS-12: Employment Status- Retired |
|
|
| MCS-12: Employment Status- Student |
|
|
| MCS-12: Employment Status- Other |
|
| MCS-12: Smoking Status- Never |
|
|
| MCS-12: Smoking Status- Former |
|
|
| MCS-12: Smoking Status- Current |
|
|
| MCS-12: Age at Onset of CD Diagnosis- At or Below 16 Years |
|
|
| MCS-12: Age at Onset of CD Diagnosis- Between 17 and 40 Years |
|
|
| MCS-12: Age at Onset of CD Diagnosis- Above 40 Years |
|
|
| MCS-12: Disease Location 1- Terminal Ileum |
|
|
| MCS-12: Disease Location 1 + 4- Terminal Ileum + Upper Gastrointestinal |
|
|
| MCS-12: Disease Location 2- Colon |
|
|
| MCS-12: Disease Location 2 + 4- Colon + Upper Gastrointestinal |
|
| MCS-12: Disease Location 3- Ileocolon |
|
|
| MCS-12: Disease Location 3 + 4- Ileocolon + Upper Gastrointestinal |
|
|
| MCS-12: Disease Location 4- Upper Gastrointestinal |
|
| MCS-12: Disease Behavior- Nonstricturing, Nonpenetrating + Perianal |
|
|
| MCS-12: Disease Behavior- Stricturing + Perianal |
|
|
| MCS-12: Disease Behavior- Penetrating + Perianal |
|
|
| MCS-12: Presence of any Extraintestinal Manifestation of CD- Yes |
|
|
| MCS-12: Presence of any Extraintestinal Manifestation of CD- No |
|
|
| MCS-12: Fistula With High Intersphincteric Type- Yes |
|
|
| MCS-12: Fistula With High Intersphincteric Type- No |
|
|
| MCS-12: Fistula With High Transsphincteric Type- Yes |
|
|
| MCS-12: Fistula With High Transsphincteric Type- No |
|
|
| MCS-12: Fistula With Suprasphincteric Type- Yes |
|
|
| MCS-12: Fistula With Suprasphincteric Type- No |
|
|
| MCS-12: Fistula With Extrasphincteric Type- Yes |
|
|
| MCS-12: Fistula With Extrasphincteric Type- No |
|
|
| MCS-12: Fistula With Superficial Type- Yes |
|
| MCS-12: Fistula With Superficial Type- No |
|
|
| MCS-12: Fistula With Low Intersphincteric Type- Yes |
|
|
| MCS-12: Fistula With Low Intersphincteric Type- No |
|
|
| MCS-12: Fistula With Low Transsphincteric Type- Yes |
|
|
| MCS-12: Fistula With Low Transsphincteric Type- No |
|
|
| MCS-12: Fistula With Midline Position- Yes |
|
|
| MCS-12: Fistula With Midline Position- No |
|
|
| MCS-12: Fistula With Lateral Position- Yes |
|
|
| MCS-12: Fistula With Lateral Position- No |
|
|
| MCS-12: Fistula With Seton- Yes |
|
|
| MCS-12: Fistula With Seton- No |
|
|
| MCS-12: HBI Category- Remission |
|
|
| MCS-12: HBI Category- Mild Activity |
|
|
| MCS-12: HBI Category- Moderate Activity |
|
|
| MCS-12: HBI Category- Severe Activity |
|
| MCS-12: Treatment-naïve- Yes |
|
|
| MCS-12: Treatment-naïve- No |
|
|
| MCS-12: Surgery-naïve- Yes |
|
|
| MCS-12: Surgery-naïve- No |
|
|
| MCS-12: Surgery - Fistulotomy- Yes |
|
|
| MCS-12: Surgery - Fistulotomy- No |
|
|
| MCS-12: Surgery - Advancement Flap- Yes |
|
| MCS-12: Surgery - Advancement Flap- No |
|
|
| MCS-12: Surgery - Ligation of the Intersphincteric Fistula Tract (LIFT) - Yes |
|
| MCS-12: Surgery - LIFT- No |
|
|
| MCS-12: Surgery - Fibrin Glue- Yes |
|
| MCS-12: Surgery - Fibrin Glue- No |
|
|
| MCS-12: Surgery - Anal Fistula Plug- Yes |
|
| MCS-12: Surgery - Anal Fistula Plug- No |
|
|
| MCS-12: Surgery - Defunctioning Stoma- Yes |
|
| MCS-12: Surgery - Defunctioning Stoma- No |
|
|
| MCS-12: Surgery - Cutting Seton-Yes |
|
| MCS-12: Surgery - Cutting Seton- No |
|
|
| MCS-12: Surgery - Loose Seton- Yes |
|
|
| MCS-12: Surgery - Loose Seton- No |
|
|
| MCS-12: Surgery - Other- Yes |
|
|
| MCS-12: Surgery - Other- No |
|
|
| MCS-12: Presence of Perianal Abscess- Yes |
|
|
| MCS-12: Presence of Perianal Abscess- No |
|
|
| MCS-12: Presence of Anorectal Stricture- Yes |
|
| MCS-12: Presence of Anorectal Stricture- No |
|
|
| Superiority |
| MCS-12: Smoking Status | ANOVA | =0.5808 | Superiority |
| MCS-12: Age at Onset | ANOVA | =0.2965 | Superiority |
| MCS-12: Disease Location | ANOVA | =0.2874 | Superiority |
| MCS-12: Disease Behavior | ANOVA | =0.4269 | Superiority |
| MCS-12: Presence of any Extraintestinal Manifestation of CD | t-test for Independent Samples | =0.8931 | Superiority |
| MCS-12: Fistula With High Intersphincteric Type | t-test for Independent Samples | =0.9384 | Superiority |
| MCS-12: Fistula With High Transsphincteric Type | Mann-Whitney | =0.8286 | Superiority |
| MCS-12: Fistula With Suprasphincteric Type | t-test for Independent Samples | =0.1919 | Superiority |
| MCS-12: Fistula with Extrasphincteric Type | t-test for Independent Samples | =0.6452 | Superiority |
| MCS-12: Fistula With Low Intersphincteric Type | t-test for Independent Samples | =0.7218 | Superiority |
| MCS-12: Fistula With Low Transsphincteric Type | t-test for Independent Samples | =0.9738 | Superiority |
| MCS-12: Fistula With Midline Position | t-test for Independent Samples | =0.2419 | Superiority |
| MCS-12: Fistula With Lateral Position | t-test for Independent Samples | =0.5524 | Superiority |
| MCS-12: Fistula With Seton | t-test for Independent Samples | =0.4443 | Superiority |
| MCS-12: HBI Categories (Remission, Mild and Moderate Activity) | ANOVA | =0.4106 | Superiority |
| MCS-12: Surgery-naïve | t-test for Independent Samples | =0.7795 | Superiority |
| MCS-12: Surgery - Fistulotomy | t-test for Independent Samples | =0.2964 | Superiority |
| MCS-12: Surgery - Loose Seton | t-test for Independent Samples | =0.3287 | Superiority |
| MCS-12: Surgery - Other | t-test for Independent Samples | =0.0091 | Superiority |
| MCS-12: Presence of Perianal Abscess | t-test for Independent Samples | =0.3889 | Superiority |
|
| PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit |
|
|
| PCS- 12: Total Number of CPFs per Participant |
|
|
| PCS- 12: Time Since Seton Placement |
|
|
| PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit |
|
|
| PCS- 12: PDAI Score |
|
|
| PCS - 12: Number of Internal Fistula Openings per Participant |
|
|
| PCS- 12: Number of External Fistula Openings per Participant |
|
|
| PCS- 12: SIBDQ Score |
|
|
| PCS- 12: SQoL-M Score |
|
|
| PCS- 12: SQoL-F Score |
|
|
| PCS- 12: Wexner Score |
|
|
| =0.4532 |
| Superiority |
| PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit | Spearman Correlation Coefficient | =0.9597 | Superiority |
| PCS- 12: Total Number of CPFs per Participant | Spearman Correlation Coefficient | =0.3304 | Superiority |
| PCS- 12: Time Since Seton Replacement | Pearson Correlation Coefficient | =0.6333 | Superiority |
| PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit | Spearman Correlation Coefficient | =0.8003 | Superiority |
| PCS- 12: PDAI Score | Pearson Correlation Coefficient | =0.0032 | Superiority |
| PCS- 12: Number of Internal Fistula Openings per Participant | Spearman Correlation Coefficient | =0.0923 | Superiority |
| PCS- 12: Number of External Fistula Openings per Participant | Spearman Correlation Coefficient | =0.0994 | Superiority |
| PCS- 12: SIBDQ Score | Pearson Correlation Coefficient | =0.0444 | Superiority |
| PCS- 12: SQoL-M Score | Pearson Correlation Coefficient | =0.0860 | Superiority |
| PCS- 12: SQoL-F Score | Pearson Correlation Coefficient | =0.9415 | Superiority |
| PCS- 12: Wexner Score | Pearson Correlation Coefficient | =0.3709 | Superiority |
|
| MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit |
|
|
| MCS- 12: Total Number of CPFs per Participant |
|
|
| MCS- 12: Time Since Seton Placement |
|
|
| MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit |
|
|
| MCS- 12: PDAI Score |
|
|
| MCS- 12: Number of Internal Fistula Openings per Participant |
|
|
| MCS- 12: Number of External Fistula Openings per Participant |
|
|
| MCS- 12: SIBDQ Score |
|
|
| MCS- 12: SQoL-M Score |
|
|
| MCS- 12: SQoL-F Score |
|
|
| MCS- 12: Wexner Score |
|
|
| =0.9392 |
| Superiority |
| MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit | Spearman Correlation Coefficient | =0.6387 | Superiority |
| MCS- 12: Total Number of CPFs per Participant | Spearman Correlation Coefficient | =0.7846 | Superiority |
| MCS- 12: Time Since Seton Placement | Pearson Correlation Coefficient | =0.3972 | Superiority |
| MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit | Spearman Correlation Coefficient | =0.9496 | Superiority |
| MCS- 12: PDAI Score | Pearson Correlation Coefficient | =0.8130 | Superiority |
| MCS- 12: Number of Internal Fistula Openings per Participant | Spearman Correlation Coefficient | =0.4588 | Superiority |
| MCS- 12: Number of External Fistula Openings per Participant | Spearman Correlation Coefficient | =0.8663 | Superiority |
| MCS- 12: SIBDQ Score | Pearson Correlation Coefficient | =0.1349 | Superiority |
| MCS- 12: SQoL-M Score | Pearson Correlation Coefficient | =0.5647 | Superiority |
| MCS- 12: SQoL-F Score | Pearson Correlation Coefficient | =0.9509 | Superiority |
| MCS- 12: Wexner Score | Pearson Correlation Coefficient | =0.5328 | Superiority |