NCT05617521

Abdominal Binder in Colonoscopies Performed by Trainees

Completed NA Results posted Last updated 1 May 2024

What this trial tests

NA trial testing Abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) in Performance of Colonoscopy in 211 participants. Completed in 28 January 2023.

Timeline

15 November 2022

Primary endpoint
25 January 2023

28 January 2023

Quick facts

Lead sponsor	Hospital Central Norte PEMEX
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	211
Start date	15 November 2022
Primary completion	25 January 2023
Estimated completion	28 January 2023
Sites	1 location across Mexico

Drugs / interventions tested

• Abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt)
• Loose abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt)

Conditions studied

• Performance of Colonoscopy — all drugs for Performance of Colonoscopy →
• Tolerance of Colonoscopy — all drugs for Tolerance of Colonoscopy →

Sponsor

Hospital Central Norte PEMEX

Who can join

Adults 20 to 80, any sex, with Performance of Colonoscopy or Tolerance of Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Cecal Intubation Time Primary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

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

Group	Value	95% CI
Abdominal Binder Intervention Group	728	544 – 902
Sham Group	774	662 – 961

Frequency of Use of Abdominal Pressure Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

Binary data indicating individually when the abdominal pressure was used during the insertion phase of the procedure will be recorded.

Group	Value	95% CI
Abdominal Binder Intervention Group	15
Sham Group	58

Length of Cecal Intubation Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

The length of the colonoscope required to reach de cecum from the anus will be measured.

Group	Value	95% CI
Abdominal Binder Intervention Group	95	90 – 100
Sham Group	100	95 – 115

Frequency of Intervention by the Attending Endoscopist Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

Binary data indicating individually if intervention by the attending endoscopist was required during the insertion phase of the procedure will be recorded.

Group	Value	95% CI
Abdominal Binder Intervention Group	6
Sham Group	11

Colonoscopy Completion Rate Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

Dichotomous outcome indicating if the procedure was complete.

Group	Value	95% CI
Abdominal Binder Intervention Group	100
Sham Group	102

Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees Secondary · Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.

Immediately following completion of procedure, the study assistant will obtain the trainee's assessment of procedural difficulty according to three grades of severity: mild, moderate, and severe. \*We found the 5-point scale more difficult to use in the dynamic of the endoscopy room. The Operator's Assessment of Procedural Difficulty scale was not used. The difficulty was rated as mild when the colonoscope was smoothly inserted, moderate when there were some difficulties quickly solved (less than 60 seconds), and severe when the difficulties were more difficult requiring a longer time (more t

Mild

Group	Value	95% CI
Abdominal Binder Intervention Group	61
Sham Group	64

Moderate

Group	Value	95% CI
Abdominal Binder Intervention Group	38
Sham Group	23

Severe

Group	Value	95% CI
Abdominal Binder Intervention Group	6
Sham Group	19

Number of Participants According to Colonoscopy Findings Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

Findings such as polyps, cancer, diverticulum, and IBD (inflammatory bowel disease) detected during colonoscopy will be recorded.

Polyps

Group	Value	95% CI
Abdominal Binder Intervention Group	36
Sham Group	30

Diverticulosis

Group	Value	95% CI
Abdominal Binder Intervention Group	42
Sham Group	44

Colon Cancer

Group	Value	95% CI
Abdominal Binder Intervention Group	0
Sham Group	1

IBD

Group	Value	95% CI
Abdominal Binder Intervention Group	1
Sham Group	0

Additional Analgesic Drug Required to Complete Procedure Secondary · During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.

Whether the patient needs an additional dose of analgesic drug to complete the colonoscopy.

Group	Value	95% CI
Abdominal Binder Intervention Group	0
Sham Group	4

Patient Pain at Discharge Secondary · At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.

The study assistant will interview patient just prior to discharge and obtain responses for pain according to a 10-point visual analog scale. The Visual analogue scale (VAS) will be used. It is a pain grading scale ranging from 0 to 10 points, with 0 if no pain and 10 if worst pain possible.

Group	Value	95% CI
Abdominal Binder Intervention Group	2.22	± 0.89
Sham Group	3.58	± 0.88

Patient Satisfaction at Discharge Secondary · At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility, an average of 90 minutes after completion of the procedure.

The study assistant will interview patient just prior to discharge and obtain responses for satisfaction according to a 5-point Likert scale. The Satisfaction Likert scale will be used. It is a satisfaction grading scale ranging from 1 to 5 points, with 1 if very poor satisfaction and 5 if excellent satisfaction.

Group	Value	95% CI
Abdominal Binder Intervention Group	3.65	± 0.78
Sham Group	3.05	± 0.88

Frequency of Use of Position Change Secondary · During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.

Binary data indicating when the patient position change was used during the insertion phase of the procedure will be recorded.

Group	Value	95% CI
Abdominal Binder Intervention Group	2
Sham Group	12

Additional Anesthetic Drug Required to Complete Procedure Secondary · During colonoscopy, from time point of insertion of scope into de rectum to point in time when scope is removed from rectum, an average of 30 minutes.

Whether the patient needs an additional dose of anesthetic drug to complete the colonoscopy.

Group	Value	95% CI
Abdominal Binder Intervention Group	0
Sham Group	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.