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Colonoscopy is considered the primary screening test for colorectal cancer screening worldwide. For technical difficulties previously experienced during colonoscopy, especially loop of the colonoscopy device in the colon, many solution methods have been developed and applied (manual pressure and position change, etc.). Although these methods are partially successful, there is no consensus on the optimum solution method. Few studies in the literature have investigated the use of corset during colonoscopy and conflicting results have been reported. In this study, elastic abdominal corset or false corset will be used during colonoscopy. Indeed, the investigators aim to determine whether this method is effective and safe with their own results and contribute to the literature. The primary outcome of this study will be the cecal intubation time. Secondary outcomes include manual pressure and position change during the procedure, length of cecal intubation (length of colonoscope required to reach the cecum from the anus), colonoscopy completion rate, additional anesthesia and / or analgesic requirement, patient pain and comfort level and colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Binder Intervention Group | Experimental | Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy. |
|
| Sham Group | Sham Comparator | Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Binder | Device | abdominal binder is a kind of elastic abdominal compression device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cecal Intubation Time | Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum | During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Required Ancillary Maneuvers | Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded. | During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes |
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Inclusion Criteria:
Between the ages of 18 - 90 Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
Participants with ASA I-III (American Society of Anesthesiologists Class III)
Exclusion Criteria:
Previous colon resection History of intra-abdominal malignancy Known anesthetic or analgesic drugs allergy Multiple planned procedures (e.g.bidirectional endoscopy) Pregnancy Active inflammatory bowel disease A history of intraabdominal malignancy History of cirrhosis or ascites Known ventral hernia
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| Name | Affiliation | Role |
|---|---|---|
| Beslen Göksoy, M.D. | Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martyr Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital | Istanbul | 34785 | Turkey (Türkiye) |
all IPD that underlie results in a publication
Starting 6 months after publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal Binder Intervention Group | Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy. Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
| FG001 | Sham Group | Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal Binder Intervention Group | Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy. Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
| BG001 |
| 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 | Mean Cecal Intubation Time | Cecal intubation time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum | 9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis. | Posted | Mean | Standard Deviation | sec | During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes |
|
Time from the start of the colonoscopy until the patient's discharge, approximately 1-2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abdominal Binder Intervention Group | Patients randomized to Abdominal Binder Intervention Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy. Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beslen Göksoy | Şehit Prof. Dr. İlhan Varank Eğitim Ve Araştırma Hastanesi | 05349530112 | beslengoksoy@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 19, 2020 | Sep 27, 2020 | Prot_SAP_ICF_000.pdf |
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| Length of Cecal Intubation | The length of the colonoscope required to reach the cecum from the anus will be measured | From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes |
| Number of Participants Who Completed the Procedure | Dichotomous outcome indicating if the procedure was incomplete or complete. | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
| Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
| Patient Pain and Comfort Level at Discharge | Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) ) | At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes |
| Number of Participants According to Colonoscopy Findings | Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded. | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
| Sham Group |
Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| waist circumference (WC) | Mean | Standard Deviation | cm |
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| OG001 | Sham Group | Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device |
|
|
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| Secondary | Number of Participants Who Required Ancillary Maneuvers | Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded. | Posted | Count of Participants | Participants | During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes |
|
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|
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| Secondary | Length of Cecal Intubation | The length of the colonoscope required to reach the cecum from the anus will be measured | 9 patients were excluded from analysis CIT and CIL because the incompleted procedure (intervention group n 4, sham group n 5). Because the procedure must be completed for CIT and CIL analysis. | Posted | Mean | Standard Deviation | cm | From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes |
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| Secondary | Number of Participants Who Completed the Procedure | Dichotomous outcome indicating if the procedure was incomplete or complete. | Posted | Count of Participants | Participants | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
|
|
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| Secondary | Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy | Posted | Count of Participants | Participants | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
|
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| Secondary | Patient Pain and Comfort Level at Discharge | Study assistant will interview patient just prior to discharge and obtain responses for pain according to 10-point visual analog scales ( scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" =1 (min) and "worst pain"=10 (max)) and global satisfaction according to a 5-point scale ( scores are recorded by making a handwritten mark on a 5-cm line that represents a continuum between "very unsatisfied" =1 (min) and "very satisfied"=5 (max) ) | Posted | Mean | Standard Deviation | score on a scale | At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes |
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| Secondary | Number of Participants According to Colonoscopy Findings | Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded. | Posted | Count of Participants | Participants | During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum,an average of 2-60 minutes |
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| 0 |
| 173 |
| 0 |
| 173 |
| 0 |
| 173 |
| EG001 | Sham Group | Sham Group will have the abdominal binder secured firmly between Spina iliaca anterior superior and subcostal area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure Abdominal Binder: abdominal binder is a kind of elastic abdominal compression device | 0 | 173 | 0 | 173 | 0 | 173 |
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| No mucosal pathology |
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| IBD or colitis |
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| colon cancer |
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