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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998255
• Other study ID #: KY20162097-5
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: September 12, 2017
• Start date: December 2016
• Est. completion date: August 2017

Study information

• Verified date: July 2017
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 940
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Department of gastroenterology, Shaanxi Second People's Hospital	Xi'an	Shaanxi
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shanxi
China	Department of gastroenterology, Qinghai Provincial People's Hospital	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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