Abdominal Compression Administered Early by the Colonoscopist During Water Exchange Colonoscopy
|ClinicalTrials.gov Identifier: NCT03954561|
Recruitment Status : Enrolling by invitation
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
- cecal intubation time [ Time Frame: through study completion, average 15 minutes ]the time when the colonoscope is inserted from the anus to the cecum.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954561
|Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation|
|Chia-Yi, Taiwan, 622|
|Principal Investigator:||Yu-Hsi Hsieh, MD||Buddhist Dalin Tzu Chi Hospital|