Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy

NCT02998255 | Completed DMC

• 1 other identifier: KY20162097-5
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 3

Brief Summary

Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost. Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.

Conditions

Health Behavior

Keywords

PEG; Bowel preparation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)

  The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.

  1 year

Secondary Outcomes (6)

• Polyp detection rate

  1 year

• Rate of adverse events

  1 year

• Cecal intubation rate

  1 year

• Cecal intubation time

  1 year

• Withdrawal time

  1 year

Study Arms (2)

Single dose of 2L PEG

EXPERIMENTAL

2 L of PEG solution was used on the day of colonoscopy.

Drug: Single dose of 2L PEG

Split-dose of 4L PEG

ACTIVE COMPARATOR

Split-dose of 4l PEG was used before and on the day of colonoscopy

Drug: Split dose of 4L PEG

Interventions

Single dose of 2L PEG DRUG

Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.

Single dose of 2L PEG

Split dose of 4L PEG DRUG

All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Split-dose of 4L PEG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing colonoscopy;
• Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
• Constipation
• Diabetes
• Parkinson's disease
• History of stroke or spine cord injure
• Prior history of inadequate bowel preparation
• BMI\>25
• Use of tricyclic antidepressant or narcotics

You may not qualify if:

• History of colorectal resection;
• Suspected colonic stricture or perforation;
• Incomplete or complete bowel obstruction;
• Use of prokinetic agents or purgatives within 7 days;
• Toxic colitis or megacolon;
• Pregnancy or lactation;
• Unable to give informed consent;
• Haemodynamically unstable.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (3)

Department of gastroenterology, Qinghai Provincial People's Hospital

Xining, Qinghai, 810000, China

Location

Department of gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, 710032, China

Location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)