The Utility of Timed Segmental Withdrawal During Screening Colonoscopy

Not Applicable

Completed

• Conditions: Colonoscopy
• Interventions: Procedure: colonoscopy

• Registration Number: NCT02132455
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief Summary

The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer. The doctor performing the procedure will first advance the colonoscope to the end of the colon (cecum) and then he will examine the colon for polyps while he is withdrawing the colonoscope. The period of time that the doctor spent examining the colon called "withdrawal time". Usually doctors will spend at least 6 minutes examining the colon after he reached the cecum. The investigators are proposing that dedicating half of the withdrawal time during colonoscopy in examining the right side of the colon, will increase the detection of polyps in the right side of the colon.

Detailed Description

Research design: This is a prospective, randomized trial comparing the ADR between patients undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time regardless of the time spent in any segment. Randomization will be done in blocks after stratification. Four gastroenterologists and two fellows matched base on similar ADR and stratified on each arm of the study (segmental versus non-segmental withdrawal) will be performing the procedures. The estimated sample size of the four arms of the study is 400 patients.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2015-12
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

• adults undergoing colonoscopy for screening or surveillance purposes

Exclusion Criteria

• prior history of colonic surgeries
• Crohn's colitis or ulcerative colitis
• prior history of colon cancer
• poor bowel preparation
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 minutes in the right side colon	colonoscopy	Colonoscopy, at least 4 minutes in the right side colon from the total withdrawal time
3 minutes in the right side colon	colonoscopy	Colonoscopy, at least 3 minutes in the right side colon from the total withdrawal time
8 minutes whole withdrawal time	colonoscopy	Colonoscopy, at least 8 minutes whole withdrawal time regardless of time spent in any segment

Primary Outcome Measures

Name	Time	Method
The Polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 6-minutes or 8-minutes protocols of the segmental withdrawal.	30 minutes	Compare PDR and ADR between patients undergoing a screening colonoscopy with at least 6-minutes protocol versus at least 8-minutes protocol within each segmental and non-segmental withdrawal protocol.
Polyp detection rate (PDR) and Adenoma detection rate (ADR) of patients undergoing a screening colonoscopy either with segmental withdrawal protocol or with non-segmental withdrawal protocol.	30 minutes	Compare polyp detection rate (PDR) and ADR between patients undergoing a screening colonoscopy with segmental withdrawal protocol and with non-segmental withdrawal protocol.

Secondary Outcome Measures

Name	Time	Method
The polyp detection rate( PDR) and Adenoma detection rate (ADR) of patients undergoing screening colonoscopy either with 3-minutes or 4-minutes protocols of the non segmental withdrawal	30 minutes	1. Compare PDR and ADR associated with different withdrawal times with segmental and non segmental withdrawal protocol. Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental and non segmental withdrawal protocol.
Complication rate	1 month	The complication rate of patients undergoing a screening colonoscopy with segmental and non segmental withdrawal protocol will be reported

Trial Locations

Locations (1)

Texas Tech University Health Science Center El Paso; 🇺🇸 El Paso, Texas, United States