Trial Outcomes & Findings for Effectiveness of Abdominal Binder Use During Colonoscopy (NCT NCT04383132)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

346 participants

Primary outcome timeframe

During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes

Results posted on

2020-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	173	173
Overall Study COMPLETED	173	173
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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	Total n=346 Participants Total of all reporting groups
Age, Continuous	50.53 years STANDARD_DEVIATION 12.3 • n=173 Participants	52.57 years STANDARD_DEVIATION 12.41 • n=173 Participants	51.55 years STANDARD_DEVIATION 12.38 • n=346 Participants
Sex: Female, Male Female	97 Participants n=173 Participants	108 Participants n=173 Participants	205 Participants n=346 Participants
Sex: Female, Male Male	76 Participants n=173 Participants	65 Participants n=173 Participants	141 Participants n=346 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	173 Participants n=173 Participants	173 Participants n=173 Participants	346 Participants n=346 Participants
Body Mass Index (BMI)	28.79 kg/m^2 STANDARD_DEVIATION 5.02 • n=173 Participants	29.62 kg/m^2 STANDARD_DEVIATION 5.54 • n=173 Participants	29.2 kg/m^2 STANDARD_DEVIATION 5.3 • n=346 Participants
waist circumference (WC)	102.33 cm STANDARD_DEVIATION 10.67 • n=173 Participants	103.26 cm STANDARD_DEVIATION 11.84 • n=173 Participants	102.8 cm STANDARD_DEVIATION 11.27 • n=346 Participants

PRIMARY outcome

Timeframe: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified,an average of 1-30 minutes

Population: 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.

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

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=169 Participants 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	Sham Group n=168 Participants 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
Mean Cecal Intubation Time	240 sec Standard Deviation 110	250 sec Standard Deviation 115

SECONDARY outcome

Timeframe: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified, an average of 1-30 minutes

Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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
Number of Participants Who Required Ancillary Maneuvers	65 Participants	85 Participants

SECONDARY outcome

Timeframe: From inserting the scope into the rectum during the colonoscopy, until the cecum base is determined, an average of 1-30 minutes

Population: 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.

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

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=169 Participants 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	Sham Group n=168 Participants 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
Length of Cecal Intubation	89 cm Standard Deviation 18	88.5 cm Standard Deviation 15

SECONDARY outcome

Timeframe: 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

Dichotomous outcome indicating if the procedure was incomplete or complete.

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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
Number of Participants Who Completed the Procedure	169 Participants	168 Participants

SECONDARY outcome

Timeframe: 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

Whether the patient needs an additional dose of anesthetic and / or analgesic drug to complete the colonoscopy

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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
Number of Participants Who Required Additional Anesthetic and / or Analgesic Drug	43 Participants	64 Participants

SECONDARY outcome

Timeframe: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility,an average of 60 minutes

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) )

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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
Patient Pain and Comfort Level at Discharge patient satisfaction score	1.7 score on a scale Standard Deviation 0.9	1.7 score on a scale Standard Deviation 0.9
Patient Pain and Comfort Level at Discharge VAS score	1.9 score on a scale Standard Deviation 1.6	3.3 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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

Findings such as polyp, cancer, diverticulum detected during colonoscopy will be recorded.

Outcome measures

Outcome measures
Measure	Abdominal Binder Intervention Group n=173 Participants 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	Sham Group n=173 Participants 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
Number of Participants According to Colonoscopy Findings Polyps	72 Participants	70 Participants
Number of Participants According to Colonoscopy Findings Diverticulosis	60 Participants	59 Participants
Number of Participants According to Colonoscopy Findings No mucosal pathology	38 Participants	42 Participants
Number of Participants According to Colonoscopy Findings IBD or colitis	0 Participants	2 Participants
Number of Participants According to Colonoscopy Findings colon cancer	3 Participants	0 Participants

Adverse Events

Abdominal Binder Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Beslen Göksoy

Şehit Prof. Dr. İlhan Varank Eğitim Ve Araştırma Hastanesi

Phone: 05349530112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place