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

NCT ID: NCT05648318

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-08
• Study Completion Date: 2022-09-12

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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Lactulose oral solution (LOS)

Group Type: EXPERIMENTAL

Lactulose oral solution

Intervention Type: DRUG

In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min.

polyethylene glycol (PEG)

Group Type: ACTIVE_COMPARATOR

PEG

Intervention Type: DRUG

patient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min

Interventions

Lactulose oral solution

In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min.

Intervention Type: DRUG

PEG

patient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhang Xiaofeng,MD

OTHER

Sponsor Role: lead

Responsible Party

Zhang Xiaofeng,MD

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaofeng Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

Hangzhou first people's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20211206301

Identifier Type: -

Identifier Source: org_study_id