Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

Sponsor
Dalin Tzu Chi General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03954561
Collaborator
(none)
120
1
2
15
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: endoscopist-administered abdominal compression
  • Procedure: assistant-administered abdominal compression
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy
Actual Study Start Date :
May 15, 2017
Actual Primary Completion Date :
Aug 14, 2018
Actual Study Completion Date :
Aug 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: endoscopist group

endoscopist-administered abdominal compression group

Procedure: endoscopist-administered abdominal compression
The endoscopist administers abdominal compression when loop formation encountered.

Active Comparator: assistant group

assistant-administered abdominal compression group

Procedure: assistant-administered abdominal compression
A assistant administers abdominal compression when loop formation encountered.

Outcome Measures

Primary Outcome Measures

  1. cecal intubation time [through study completion, average 15 minutes]

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

Secondary Outcome Measures

  1. proportion of patients requiring abdominal compression by an assistant [through study completion, average 15 minutes]

    proportion of patients requiring abdominal compression by an assistant

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Chia-Yi Taiwan 622

Sponsors and Collaborators

  • Dalin Tzu Chi General Hospital

Investigators

  • Principal Investigator: Yu-Hsi Hsieh, MD, Buddhist Dalin Tzu Chi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yu-Hsi hsieh, Chief of Gastroenterology Endoscopy Suite, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT03954561
Other Study ID Numbers:
  • A10601001
First Posted:
May 17, 2019
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu-Hsi hsieh, Chief of Gastroenterology Endoscopy Suite, Dalin Tzu Chi General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021