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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Drug: Single dose of 2L PEG; Drug: Split dose of 4L PEG

• Study Type: Interventional
• Enrollment (Actual): 940
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Department of gastroenterology, Qinghai Provincial People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Department of gastroenterology, Shaanxi Second People's Hospital
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Endoscopic center, Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose of 2L PEG; 2 L of PEG solution was used on the day of colonoscopy.	Drug: Single dose of 2L PEG; 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.
Active Comparator: Split-dose of 4L PEG; Split-dose of 4l PEG was used before and on the day of colonoscopy	Drug: Split dose of 4L PEG; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal time		1 year
Polyp detection rate		1 year
Rate of adverse events	adverse events, such as vomiting, nausea, headache, abdominal pain	1 year
Cecal intubation rate		1 year
Cecal intubation time		1 year
Willingness to repeat bowel preparation	The number of patients have a willingness to undergo a repeated bowel preparation if needed	1 year

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 30, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Colonoscopy; PEG; Bowel preparation
• Other Study ID Numbers: KY20162097-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO