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

NCT05648318 | Completed

• 1 other identifier: 20211206301
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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

Keywords

colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Bowel preparation

  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.

  1hour

Secondary Outcomes (6)

• Adverse events

  1hour

• Willingness to repeat bowel preparation

  1hour

• Adenoma detection rate

  7 days

• Cecal intubation rate

  1hour

• insertion time

  1hour

Study Arms (2)

Lactulose oral solution (LOS)

EXPERIMENTAL

Drug: Lactulose oral solution

polyethylene glycol (PEG)

ACTIVE COMPARATOR

Drug: PEG

Interventions

Lactulose oral solution 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.

Lactulose oral solution (LOS)

PEG 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

polyethylene glycol (PEG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhang Xiaofeng,MD: lead

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Xiaofeng Zhang, MD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 8, 2022
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

CN (1)