Trial Outcomes & Findings for Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection (NCT NCT02581475)

Results Overview

Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

386 participants

Primary outcome timeframe

During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.

Results posted on

2016-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Extending Withdrawal Time After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
Overall Study STARTED	193	193
Overall Study COMPLETED	182	178
Overall Study NOT COMPLETED	11	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Segmental Examination Twice of the Proximal Colon on Adenoma Detection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Extending Withdrawal Time n=182 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice n=178 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.	Total n=360 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 10.3 • n=5 Participants	55.0 years STANDARD_DEVIATION 11.0 • n=7 Participants	54.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	83 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	95 Participants n=7 Participants	197 Participants n=5 Participants

PRIMARY outcome

Timeframe: During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.

Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.

Outcome measures

Outcome measures
Measure	Extending Withdrawal Time n=182 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice n=178 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.	0.236 proportion of participants Interval 0.175 to 0.298	0.331 proportion of participants Interval 0.262 to 0.4

SECONDARY outcome

Timeframe: During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.

Outcome measures

Outcome measures
Measure	Extending Withdrawal Time n=182 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice n=178 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
Withdrawal Time in the Proximal Colon Among 2 Group.	4.34 minute Standard Deviation 1.36	4.29 minute Standard Deviation 1.23

SECONDARY outcome

Timeframe: During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.

Outcome measures

Outcome measures
Measure	Extending Withdrawal Time n=182 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice n=178 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
Duration of the Total Colonoscopy Among 2 Group.	16.98 minute Standard Deviation 4.92	17.45 minute Standard Deviation 5.25

SECONDARY outcome

Timeframe: During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.

Outcome measures

Outcome measures
Measure	Extending Withdrawal Time n=182 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.	Segmental Examination Twice n=178 Participants After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
Adenomas Per Patient in the Proximal Colon Among 2 Group.	0.36 adenomas per patient Standard Deviation 0.704	0.54 adenomas per patient Standard Deviation 0.921

Adverse Events

Extending Withdrawal Time

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Segmental Examination Twice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yanqing Li

Shandong University Qilu Hospital

Phone: +86-531-82169236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place