N/A
N=211
Abdominal Binder in Colonoscopies Performed by Trainees
Performance of Colonoscopy · Tolerance of Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT05617521 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Mean Cecal Intubation Time — 728; 774 second — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) (Device); Loose abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Hospital Central Norte PEMEX
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cecal Intubation Time |
728; 774 | 0.008 sig |
| SECONDARY Frequency of Use of Abdominal Pressure |
15; 58 | <0.001 sig |
| SECONDARY Length of Cecal Intubation |
95; 100 | <0.001 sig |
| SECONDARY Frequency of Intervention by the Attending Endoscopist |
6; 11 | 0.321 |
| SECONDARY Colonoscopy Completion Rate |
100; 102 | 0.75 |
| SECONDARY Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees |
61; 64; 38; 23; 6; 19 | 0.005 sig |
| SECONDARY Number of Participants According to Colonoscopy Findings |
36; 30; 42; 44; 0; 1 | 0.8 |
| SECONDARY Operator Perception of Patient Discomfort |
— | — |
| SECONDARY Additional Analgesic Drug Required to Complete Procedure |
0; 4 | 0.12 |
| SECONDARY Patient Pain at Discharge |
2.22; 3.58 | <0.001 sig |
| SECONDARY Patient Satisfaction at Discharge |
3.65; 3.05 | <0.001 sig |
| SECONDARY Frequency of Use of Position Change |
2; 12 | 0.01 sig |
| SECONDARY Additional Anesthetic Drug Required to Complete Procedure |
0; 0 | 1 |
Summary
This randomized trial will be conducted to evaluate the effectiveness and safety of an abdominal binder use during colonoscopy performed by gastrointestinal endoscopy fellow trainees. The investigators hypothesized that the abdominal binder use would facilitate and increase the effectiveness of the colonoscopy for inexperienced operators.
Eligibility Criteria
Inclusion Criteria
- Male and female adults between the ages of 20-80
- Participants with ASA I-III (American Society of Anesthesiologists Class)
- Undergoing a colonoscopy at any of the study locations for:
I. CRC screening (first colonoscopy or 10 years follow up of negative exam). II. Surveillance (prior colonoscopy with polyps). III. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.
- Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure and describe adequate cleansing.
Exclusion Criteria
- Inability to provide informed consent.
- Patients with known or suspected pregnancy.
- Patients undergoing multiple procedures (e.g., upper and lower endoscopy).
- Previous colon resection surgery.
- History of problems with sedation or anesthesia.
- Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- Patients with a history of colorectal cancer or other intra-abdominal malignancy.
- Patients with open or recent wounds or skin rash on the anterior abdominal wall.
- History of cirrhosis or ascites.
- Patients who are medically unstable (American Society of Anesthesiology Class IV or above).
Data sourced from ClinicalTrials.gov (NCT05617521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.