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Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

NCT ID: NCT03356015

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation Scale Adenoma Detection Rate

Keywords

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Polyp detection rate Adenoma detection rate Boston Bowel Preparation Scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

4L Polyethylene Glycol

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

3L Polyethylene Glycol

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept and Digestive Endoscopy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Cheng

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Zhaosheng Li, MD

Role: CONTACT

Phone: +86-21-25070552

Email: [email protected]

Yu Bai, MD

Role: CONTACT

Phone: +86-13564665324

Email: [email protected]

References

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Cheng P, Chen Q, Li J, Pang L, Feng C, Wang N, Bai Y, Li Z, Meng X. 3 liters of polyethylene glycol vs. standard bowel preparation have equal efficacy in a Chinese population: a randomized, controlled trial. Am J Transl Res. 2022 Aug 15;14(8):5641-5650. eCollection 2022.

Reference Type DERIVED
PMID: 36105041 (View on PubMed)

Other Identifiers

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PEG-171116

Identifier Type: -

Identifier Source: org_study_id