Abdominal Binder in Colonoscopies Performed by Trainees

NCT ID: NCT05617521

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-01-28

Brief 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.

Detailed Description

It will be a randomized, double-blind, sham-controlled study. The trial will be performed at a single-center, Hospital Central Norte PEMEX, a tertiary center with a gastrointestinal endoscopy fellow trainee program with more than 10 years of experience. This trial will be conducted in accordance with the most recent version of the Declaration of Helsinki. The trial has been approved by the local ethical committee and research committee with the number DCAS-SSS GSM-HCN-INV-0043-2022. Written informed consent will be obtained from all the patients before participation. This manuscript will be reported in accordance with CONSORT guidelines.

Prior to the procedure, age, sex, height, weight, waist circumference (WC), body mass index (BMI), and colonoscopy indication of all participants will be recorded. Once enrolled, patients will be randomized to either the abdominal binder (AB) group or the sham binder (SB) group in a 1:1 ratio. Randomization will be performed using a web-based computer system (Research Randomizer, Geoffrey C. Urbaniak and Scott Plous) by an independent statistician who had no other intervention in the study. An independent operator will print the randomization number and group for each participant (either the AB or SB group) in individual cards, which will be hidden in a locked black box by the same independent operator. Only the nurse, who will fit the abdominal binder to all the patients in a private space, will have access to the cards. Randomized data and cards will be concealed to study coordinators, endoscopists, clinical staff, and participants.

The abdominal binder to be used for the patients allocated in the AB group was the Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). Its price is $29.96. The device is manufactured in two sizes, One Size and X-Large. For the patients with a waist circumference >110 cm it will be used the X-Large model. The three belts that make up the binder will be fitted to all the participants. Once placed, the binder will be adjusted to be located between the subcostal border and the anterior superior iliac spine. The participants will be asked to confirm that the binder is fastened tightly but not uncomfortably. For the participants in the SB group the same binder will be fitted, but once the patient is sedated, it will be loosened by the same nurse. The participants will wear a non-transparent gown over the binder so that it will not be visible to the endoscopists.

Bowel preparation with 4 L of polyethylene glycol solution in split-dose (2 L in the afternoon of the day before and 5 h before the colonoscopy) will be used in all the participants. In this trial, all colonoscopy procedures will be performed by two second-year fellow trainees in gastrointestinal endoscopy.

A standard video-colonoscope (EC-3890Li, PENTAX Co., Tokyo, Japan) will be used. All the patients will be placed in the left lateral decubitus position. Manual abdominal compression and postural change will be conducted by a technician when required by the endoscopy trainee or the attending endoscopist. Endoscopist or anesthesiology will be allowed to remove the binder at any time during the procedure if they resolve it was necessary for safety. Air insufflation will be used during colonoscopy.

Sample size was estimated over the primary outcome of the study based on pre-experimental data estimation and previously reported CIT and SD of similar studies with fellows' participation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT (SD 110 sec), with 90% power and two-side alpha 0.05. Moreover, it was also calculated based on the frequency of ancillary maneuvers, using pre-experimental data estimation and literature data. It was found that 186 participants (93 per group) were needed to detect a 20% reduction in the use of ancillary maneuvers, with 90% power and two-side alpha 0.05. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients, 103 in each group were included in the study.

Descriptive statistical analysis, including mean, mode, and frequencies will be performed for the description of the study data. The comparative analysis of the quantitative data will be previously subjected to normality evaluation by the Shapiro-Wilk test and graphical analyses. According to the normality, data comparative analysis will be performed either with a two-way Student's test or U Mann-Whitney test. For the comparative analyses of the categorical data (e.g., manual abdominal compression, postural change, need for intervention by the attending endoscopist) will be used chi-square or Fisher' exact test. A p value of <0.05 will be accepted as statistical significance. Statistical inferential analysis will be performed using RStudio® (R Core Team v.1.2.5033; R Foundation for Statistical Computing, Vienna, Austria) and SPSS® Statistics for Windows Version 23.0 (IBM Corp., Armonk, NY, USA). RStudio® (R Core Team v.1.2.5033) will be also used for drawing graphics. The study biostatistician (SA) will be blinded to the randomization phase and recollection data process.

Conditions

Performance of Colonoscopy; Tolerance of Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Abdominal Binder Intervention Group

Patients randomized to the Abdominal Binder Intervention Group will have the abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) secured firmly between the subcostal border and the anterior superior iliac spine area to the abdomen just prior the colonoscopy.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device

Sham Group

Sham Group will have the abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt) secured firmly between the subcostal border and the anterior superior iliac spine area to the abdomen just prior the colonoscopy but it will be loosened just prior the procedure.

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device. It will be loosened just prior the procedure.

Interventions

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

Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device

Intervention Type: DEVICE

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

Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA). An abdominal binder is a kind of elastic abdominal compression device. It will be loosened just prior the procedure.

Intervention Type: DEVICE

Other Intervention Names

Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA); Revive 3-in-1 abdominal binder; Revive 3-in-1 Postpartum Recovery Support Belt (KeaBabies® Co., CA, USA); Revive 3-in-1 abdominal binder

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Central Norte PEMEX

OTHER

Sponsor Role: lead

Responsible Party

Antonio Marmolejo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Arellano, M.D

Role: STUDY_CHAIR

Ethical committee president of the Hospital Central Norte PEMEX

Locations

Antonio Marmolejo

Mexico City, , Mexico

Countries

Mexico

References

Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.

Reference Type: BACKGROUND

PMID: 25480100 (View on PubMed)

Toyoshima O, Nishizawa T, Sakitani K, Yamakawa T, Yoshida S, Fukagawa K, Hata K, Ishihara S, Suzuki H. Colonoscopy using back brace support belt: A randomized, prospective trial. JGH Open. 2019 Nov 7;4(3):441-445. doi: 10.1002/jgh3.12276. eCollection 2020 Jun.

Reference Type: BACKGROUND

PMID: 32514451 (View on PubMed)

Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.

Reference Type: BACKGROUND

PMID: 26767313 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DCAS-SSS GSM-HCN-INV-0043-2022

Identifier Type: -

Identifier Source: org_study_id