An interventional study of Abdominal Binder in Performance and Tolerance of Colonoscopy, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Not applicable, Interventional, and Prevention
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.
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 38 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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.
Device: Abdominal Binder
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
Device: Abdominal Binder
abdominal binder is a kind of elastic abdominal compression device
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
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes
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.
Time frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes
Length of Cecal Intubation
The length of the colonoscope required to reach the cecum from the anus will be measured
Time frame: 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.
Time frame: 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
Time frame: 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) )
Time frame: 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.
Time frame: 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
| Milestone | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Started | 173 | 173 |
| Completed | 173 | 173 |
| Not completed | 0 | 0 |
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
| sec | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Mean Cecal Intubation Time | 240 ± 110 | 250 ± 115 |
Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.
| Participants | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Number of Participants Who Required Ancillary Maneuvers | 65 | 85 |
The length of the colonoscope required to reach the cecum from the anus will be measured
| cm | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Length of Cecal Intubation | 89 ± 18 | 88.5 ± 15 |
Dichotomous outcome indicating if the procedure was incomplete or complete.
| Participants | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Number of Participants Who Completed the Procedure | 169 | 168 |
Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy
| Participants | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug | 43 | 64 |
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) )
| score on a scale | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| VAS score | 1.9 ± 1.6 | 3.3 ± 1.8 |
| patient satisfaction score | 1.7 ± 0.9 | 1.7 ± 0.9 |
Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.
| Participants | Abdominal Binder Intervention Group | Sham Group |
|---|---|---|
| Polyps | 72 | 70 |
| Diverticulosis | 60 | 59 |
| No mucosal pathology | 38 | 42 |
| IBD or colitis | 0 | 2 |
| colon cancer | 3 | 0 |
Collected over Time from the start of the colonoscopy until the patient's discharge, approximately 1-2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abdominal Binder Intervention Group | 0/173 (0%) | 0/173 (0%) | 0/173 (0%) |
| Sham Group | 0/173 (0%) | 0/173 (0%) | 0/173 (0%) |
| Age, Continuous(years) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Mean | 50.53 ± 12.3 | 52.57 ± 12.41 | 51.55 ± 12.38 |
| Sex: Female, Male(Participants) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Female | 97 | 108 | 205 |
| Male | 76 | 65 | 141 |
| Race and Ethnicity Not Collected(Participants) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Turkey | 173 | 173 | 346 |
| Body Mass Index (BMI)(kg/m^2) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Mean | 28.79 ± 5.02 | 29.62 ± 5.54 | 29.2 ± 5.3 |
| waist circumference (WC)(cm) | Abdominal Binder Intervention Group | Sham Group | Total |
|---|---|---|---|
| Mean | 102.33 ± 10.67 | 103.26 ± 11.84 | 102.8 ± 11.27 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Icf, Csr
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital