Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients eligible for laparoscopic ventral mesh rectopexy | Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ifabond (Péters surgical) | Device | Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | During procedure |
| Procedural efficacy - Conversion rate to laparotomy during the index procedure | Number of conversions to laparotomy during the index procedure | During procedure |
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | At discharge (assessed up to 1 week) |
| Procedural efficacy - Number of re-interventions | Number of re-interventions | At discharge (assessed up to 1 week) |
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | Follow-up 1: 6 - 10 weeks after the procedure |
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 1: 6 - 10 weeks after the procedure |
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 1: 6 - 10 weeks after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS) | Assessment of pre-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | At baseline |
| Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie De Munter, PhD | Contact | +32 (0)11 28 69 48 | stephanie.de.munter@archerresearch.eu | |
| Anne Dams, MD | Contact | +32 (0)89 32 60 20 | anne.dams@zol.be |
| Name | Affiliation | Role |
|---|---|---|
| Anne Dams, MD | Ziekenhuis Oost-Limburg (ZOL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg (ZOL) | Recruiting | Genk | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020047 | Rectocele |
| D006547 | Hernia |
| D012005 | Rectal Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | Follow-up 2: 12 months after the procedure |
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 2: 12 months after the procedure |
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 2: 12 months after the procedure |
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | Follow-up 3: 24 months after the procedure |
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 3: 24 months after procedure |
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 3: 24 months after the procedure |
| Procedural efficacy - Number of participants with (serious) adverse events | Number of participants with (serious) adverse events ≥ grade II Clavien-Dindo | Follow-up 4: 36 months after the procedure |
| Procedural efficacy - Number of re-interventions | Number of re-interventions | Follow-up 4: 36 months after the procedure |
| Procedural efficacy - Number of post-operative recurrences | Number of post-operative recurrences | Follow-up 4: 36 months after the procedure |
Assessment of pre-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. |
| At baseline |
| Functional score - Obstructive Defecation Syndrome (ODS) score | The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms. | At baseline |
| Functional score - Cleveland Clinical Incontinence Score (CCIS) | The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms. | At baseline |
| Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms. | At baseline |
| Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 1: 6 - 10 weeks after the procedure |
| Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 2: 12 months after the procedure |
| Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 3: 24 months after the procedure |
| Post-operative abdominal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 4: 36 months after the procedure |
| Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 1: 6 - 10 weeks after the procedure |
| Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 2: 12 months after the procedure |
| Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 3: 24 months after the procedure |
| Post-operative vaginal pain by means of the Visual Analogue Scale (VAS) | Assessment of post-operative vaginal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. | Follow-up 4: 36 months after the procedure |
| Functional score - Obstructive Defecation Syndrome (ODS) score | The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms. | Follow-up 1: 6 - 10 weeks after the procedure |
| Functional score - Obstructive Defecation Syndrome (ODS) score | The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms. | Follow-up 2: 12 months after the procedure |
| Functional score - Obstructive Defecation Syndrome (ODS) score | The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms. | Follow-up 3: 24 months after the procedure |
| Functional score - Obstructive Defecation Syndrome (ODS) score | The ODS score is obtained by means of a structured 8-item questionnaire on multiple bowel symptoms. The cumulative score for all answers ranges from 0 to 31, with higher scores being indicative of more severe symptoms. | Follow-up 4: 36 months after the procedure |
| Functional score - Cleveland Clinical Incontinence Score (CCIS) | The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms. | Follow-up 1: 6 - 10 weeks after the procedure |
| Functional score - Cleveland Clinical Incontinence Score (CCIS) | The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms. | Follow-up 2: 12 months after the procedure |
| Functional score - Cleveland Clinical Incontinence Score (CCIS) | The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms. | Follow-up 3: 24 months after the procedure |
| Functional score - Cleveland Clinical Incontinence Score (CCIS) | The CCIS is a 5-item questionnaire used to score the level of fecal incontinence. The cumulative score ranges from 0 to 20, with higher scores being indicative of more severe symptoms. | Follow-up 4: 36 months after the procedure |
| Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms. | Follow-up 1: 6 - 10 weeks after the procedure |
| Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinart symptoms. Higher scores are indicative of more severe symptoms. | Follow-up 2: 12 months after the procedure |
| Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms. | Follow-up 3: 24 months after the procedure |
| Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ) | The BBUSQ is a 22-item questionnaire to record data on 4 domains: constipation, evacuation, incontinence and urinary symptoms. Higher scores are indicative of more severe symptoms. | Follow-up 4: 36 months after the procedure |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |