Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

Not Applicable

Completed

• Conditions: Colonic Neoplasms
• Interventions: Drug: Lactulose oral solution; Drug: PEG

• Registration Number: NCT05648318
• Lead Sponsor: Zhang Xiaofeng,MD

Brief Summary

Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel preparation.However, due to the poor palatability, there still more than 30% patients with 2L regimen experienced nausea or vomiting in our center.

Oral lactulose is a treatment for constipation. Several studies have compared the effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk patients. However, the data in low-risk patients is vacant. The objective of current study was to compared the effectiveness of bowel preparation and patient tolerance using lactulose and 2L PEG regimen in low-risk patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2022-12
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Last Update Submitted: 2022-12-05
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Patients over 18 years old and with low-risk were eligible. Patients were considered as low risk if they did not meet any of the following risk factors: age>70 years old, body mass index (BMI)>25Kg/m2, constipation, Parkinson's disease, diabetes, history of stroke or spinal cord injury, use of tricyclic antidepressant or narcotics.

Exclusion Criteria

• (1) history of colorectal resection; (2) Known or suspected colonic stricture or obstructing tumor; (3) Known or suspected colonic perforation; (4) toxic colitis or megacolon; (5) use of prokinetic agents or purgatives within 7 days; (6) hemodynamic instability; (7) pregnancy or lactation; (8) inability to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose oral solution (LOS)	Lactulose oral solution	-
polyethylene glycol (PEG)	PEG	-

Primary Outcome Measures

Name	Time	Method
Bowel preparation	1hour	Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

Secondary Outcome Measures

Name	Time	Method
withdrawal time	1hour
Cecal intubation rate	1hour
Adverse events	1hour
Willingness to repeat bowel preparation	1hour	We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again
Adenoma detection rate	7 days
insertion time	1hour

Trial Locations

Locations (1)

Hangzhou first people's Hospital; 🇨🇳 Hangzhou, Zhejiang, China