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Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

Primary Purpose

Colonic Polyp, Colonic Adenoma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
endoscopist-administered abdominal compression
assistant-administered abdominal compression
Sponsored by
Dalin Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp focused on measuring colonoscopy, cecal intubation time

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
  • Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included.

Exclusion Criteria:

  • Included patient declined to give consent,
  • age <20 years old,
  • age >80 years old,
  • previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35).

Sites / Locations

  • Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endoscopist group

assistant group

Arm Description

endoscopist-administered abdominal compression group

assistant-administered abdominal compression group

Outcomes

Primary Outcome Measures

cecal intubation time
the time when the colonoscope is inserted from the anus to the cecum.

Secondary Outcome Measures

proportion of patients requiring abdominal compression by an assistant
proportion of patients requiring abdominal compression by an assistant

Full Information

First Posted
June 10, 2017
Last Updated
June 28, 2021
Sponsor
Dalin Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03954561
Brief Title
Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy
Official Title
Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalin Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time. The loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation. A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp, Colonic Adenoma
Keywords
colonoscopy, cecal intubation time

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopist group
Arm Type
Experimental
Arm Description
endoscopist-administered abdominal compression group
Arm Title
assistant group
Arm Type
Active Comparator
Arm Description
assistant-administered abdominal compression group
Intervention Type
Procedure
Intervention Name(s)
endoscopist-administered abdominal compression
Intervention Description
The endoscopist administers abdominal compression when loop formation encountered.
Intervention Type
Procedure
Intervention Name(s)
assistant-administered abdominal compression
Intervention Description
A assistant administers abdominal compression when loop formation encountered.
Primary Outcome Measure Information:
Title
cecal intubation time
Description
the time when the colonoscope is inserted from the anus to the cecum.
Time Frame
through study completion, average 15 minutes
Secondary Outcome Measure Information:
Title
proportion of patients requiring abdominal compression by an assistant
Description
proportion of patients requiring abdominal compression by an assistant
Time Frame
through study completion, average 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan. Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included. Exclusion Criteria: Included patient declined to give consent, age <20 years old, age >80 years old, previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsi Hsieh, MD
Organizational Affiliation
Buddhist Dalin Tzu Chi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Chia-Yi
ZIP/Postal Code
622
Country
Taiwan

12. IPD Sharing Statement

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Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

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