Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy

NCT03954561 | Completed DMC

• 1 other identifier: A10601001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp; Colonic Adenoma

Keywords

colonoscopy; cecal intubation time

Outcome Measures

Primary Outcomes (1)

• cecal intubation time

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

  through study completion, average 15 minutes

Secondary Outcomes (1)

• proportion of patients requiring abdominal compression by an assistant

  through study completion, average 15 minutes

Study Arms (2)

endoscopist group

EXPERIMENTAL

endoscopist-administered abdominal compression group

Procedure: endoscopist-administered abdominal compression

assistant group

ACTIVE COMPARATOR

assistant-administered abdominal compression group

Procedure: assistant-administered abdominal compression

Interventions

endoscopist-administered abdominal compression PROCEDURE

The endoscopist administers abdominal compression when loop formation encountered.

endoscopist group

assistant-administered abdominal compression PROCEDURE

A assistant administers abdominal compression when loop formation encountered.

assistant group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, Taiwan, 622, Taiwan

Location

Related Publications (19)

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MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Hsi Hsieh, MD

  Buddhist Dalin Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology Endoscopy Suite

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: May 17, 2019
• Study Start: May 15, 2017
• Primary Completion: August 14, 2018
• Study Completion: August 14, 2018
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

TW (1)