Trial Outcomes & Findings for Abdominal Binder in Colonoscopies Performed by Trainees (NCT NCT05617521)
NCT ID: NCT05617521
Last Updated: 2024-05-01
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
211 participants
Primary outcome timeframe
During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
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.
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
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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.
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.
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|---|---|---|
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Overall Study
STARTED
|
105
|
106
|
|
Overall Study
COMPLETED
|
105
|
106
|
|
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
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
|
Total
n=211 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
63.36 years
STANDARD_DEVIATION 11.98 • n=105 Participants
|
65.33 years
STANDARD_DEVIATION 12.34 • n=106 Participants
|
64.35 years
STANDARD_DEVIATION 12.17 • n=211 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=105 Participants
|
67 Participants
n=106 Participants
|
129 Participants
n=211 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=105 Participants
|
39 Participants
n=106 Participants
|
82 Participants
n=211 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
105 participants
n=105 Participants
|
106 participants
n=106 Participants
|
211 participants
n=211 Participants
|
|
Body Mass Index (IBM)
|
29 kg/m^2
n=105 Participants
|
27.4 kg/m^2
n=106 Participants
|
28.4 kg/m^2
n=211 Participants
|
|
Height
|
1.64 meter
STANDARD_DEVIATION 0.09 • n=105 Participants
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1.64 meter
STANDARD_DEVIATION 0.07 • n=106 Participants
|
1.64 meter
STANDARD_DEVIATION 0.08 • n=211 Participants
|
|
Weight
|
78.44 kilogram
STANDARD_DEVIATION 15.93 • n=105 Participants
|
74.42 kilogram
STANDARD_DEVIATION 13.92 • n=106 Participants
|
76.42 kilogram
STANDARD_DEVIATION 15.05 • n=211 Participants
|
PRIMARY outcome
Timeframe: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.Population: 8 participants with incomplete colonoscopy were excluded from the primary outcome analysis (intervention group n 4, sham group n 4).
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
| Measure |
Abdominal Binder Intervention Group
n=101 Participants
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.
|
Sham Group
n=102 Participants
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.
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|---|---|---|
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Mean Cecal Intubation Time
|
728 second
Interval 544.0 to 902.0
|
774 second
Interval 662.0 to 961.0
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Frequency of Use of Abdominal Pressure
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15 Participants
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58 Participants
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SECONDARY outcome
Timeframe: During colonoscopy, from insertion of scope into rectum to point in time when base of the cecum is identified, an average of 30 minutes.Population: Participants with incomplete colonoscopy were excluded from two of the main secondary outcomes (CIL and IVIT).
The length of the colonoscope required to reach de cecum from the anus will be measured.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=101 Participants
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.
|
Sham Group
n=102 Participants
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.
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|---|---|---|
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Length of Cecal Intubation
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95 centimeter
Interval 90.0 to 100.0
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100 centimeter
Interval 95.0 to 115.0
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Frequency of Intervention by the Attending Endoscopist
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6 Participants
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11 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Colonoscopy Completion Rate
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100 Participants
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102 Participants
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SECONDARY outcome
Timeframe: 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 than 60 seconds).
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees
Mild
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61 Participants
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64 Participants
|
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Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees
Moderate
|
38 Participants
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23 Participants
|
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Number of Participants With Mild, Moderate, and Severe Procedural Difficulty as Assessed by Trainees
Severe
|
6 Participants
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19 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Number of Participants According to Colonoscopy Findings
Diverticulosis
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42 Participants
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44 Participants
|
|
Number of Participants According to Colonoscopy Findings
Polyps
|
36 Participants
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30 Participants
|
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Number of Participants According to Colonoscopy Findings
Colon Cancer
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0 Participants
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1 Participants
|
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Number of Participants According to Colonoscopy Findings
IBD
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1 Participants
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0 Participants
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SECONDARY outcome
Timeframe: Immediately following completion of procedure when scope is removed from rectum, an average of 10 minutes after completion of the procedure.Population: We found the use of the Gloucester score difficult and subjective to use in the clinical scenario. The operators rated the episodes of discomfort in different ways, showing since the beginning a lack of consistency. The operator perception of patient discomfort was not evaluated. The data of this outcome were not collected for any patient.
Immediately following completion of procedure, the study assistant will obtain operator's perception of patient discomfort during procedure according to the Gloucester score. The Gloucester score will be used. It is a comfort grading scale ranging from 1 to 5 points, with 1 point if no discomfort is present during the colonoscopy and 5 if there is extreme discomfort during the colonoscopy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Additional Analgesic Drug Required to Complete Procedure
|
0 Participants
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4 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Patient Pain at Discharge
|
2.22 score on a scale
Standard Deviation 0.89
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3.58 score on a scale
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Patient Satisfaction at Discharge
|
3.65 score on a scale
Standard Deviation 0.78
|
3.05 score on a scale
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
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|---|---|---|
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Frequency of Use of Position Change
|
2 Participants
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12 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Abdominal Binder Intervention Group
n=105 Participants
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.
|
Sham Group
n=106 Participants
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.
|
|---|---|---|
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Additional Anesthetic Drug Required to Complete Procedure
|
0 Participants
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0 Participants
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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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place