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Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

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ClinicalTrials.gov Identifier: NCT03954561
Recruitment Status : Enrolling by invitation
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

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
Colonic Polyp Colonic Adenoma Procedure: endoscopist-administered abdominal compression Procedure: assistant-administered abdominal compression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. cecal intubation time [ Time Frame: 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 [ Time Frame: through study completion, average 15 minutes ]
    proportion of patients requiring abdominal compression by an assistant



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954561


Locations
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Taiwan
Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chia-Yi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Principal Investigator: Yu-Hsi Hsieh, MD Buddhist Dalin Tzu Chi Hospital

Publications:

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Responsible Party: Yu-Hsi hsieh, Chief of Gastroenterology Endoscopy Suite, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03954561     History of Changes
Other Study ID Numbers: A10601001
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yu-Hsi hsieh, Dalin Tzu Chi General Hospital:
colonoscopy
cecal intubation time

Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical