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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
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 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. 4L-group received 4bags of PEG and were instructed to drink 2 L 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. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.

Condition or disease Intervention/treatment Phase
Bowel Preparation Scale Adenoma Detection Rate Drug: 4L Polyethylene Glycol Drug: 3L Polyethylene Glycol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: 2 days ]
    The secondary end point of the study included polyp detection rate

  2. Adenoma detection rate [ Time Frame: 2 days ]
    The secondary end point of the study included adenoma detection rate

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Outpatients aged 18-75 years
  2. Referred for routine diagnostic colonoscopy
  3. Patients who have signed inform consent form

Exclusion Criteria:

  1. pregnancy or breastfeeding
  2. allergy to purgatives
  3. suspected intestinal obstruction, stricture, or perforation
  4. hemodynamic instability
  5. impaired swallowing reflex or mental status
  6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
  7. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
  8. participation declined.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhaosheng Li, MD +86-21-25070552 zhaoshenlismmu@gmail.com
Contact: Yu Bai, MD +86-13564665324 baiyu1998@hotmail.com

Locations
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China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Peng Cheng Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept and Digestive Endoscopy Center, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03356015     History of Changes
Other Study ID Numbers: PEG-171116
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaoshen Li, Changhai Hospital:
Polyp detection rate
Adenoma detection rate
Boston Bowel Preparation Scale
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms