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

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Drug: Split dose of 4L PEG; Drug: Single dose of 2L PEG

• Registration Number: NCT02998255
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Status Verified: 2017-07
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 940

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Split-dose of 4L PEG	Split dose of 4L PEG	Split-dose of 4l PEG was used before and on the day of colonoscopy
Single dose of 2L PEG	Single dose of 2L PEG	2 L of PEG solution was used on the day of colonoscopy.

Primary Outcome Measures

Name	Time	Method
Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Department of gastroenterology, Qinghai Provincial People's Hospital; 🇨🇳 Xining, Qinghai, China

Department of gastroenterology, Shaanxi Second People's Hospital; 🇨🇳 Xi'an, Shaanxi, China

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shanxi, China