Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
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|ClinicalTrials.gov Identifier: NCT03356015|
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bowel Preparation Scale Adenoma Detection Rate||Drug: 4L Polyethylene Glycol Drug: 3L Polyethylene Glycol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation|
|Estimated Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||January 1, 2018|
|Estimated Study Completion Date :||February 1, 2018|
Experimental: 4L Polyethylene Glycol
4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
Drug: 4L Polyethylene Glycol
4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes.
Active Comparator: 3L Polyethylene Glycol
3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate.
Drug: 3L Polyethylene Glycol
3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes
- the Boston Bowel Preparation Scale [ Time Frame: 2 days ]The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2
- Polyp detection rate [ Time Frame: 2 days ]The secondary end point of the study included polyp detection rate
- Adenoma detection rate [ Time Frame: 2 days ]The secondary end point of the study included adenoma detection rate
- The mean number of incremental adenomas [ Time Frame: 2 days ]It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
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): NCT03356015
|Contact: Zhaosheng Li, MDemail@example.com|
|Contact: Yu Bai, MDfirstname.lastname@example.org|
|Changhai Hospital, Second Military Medical University|
|Shanghai, China, 200433|
|Principal Investigator:||Peng Cheng||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|