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

Sponsor

Zhang Xiaofeng,MD (Other)

Overall Status

Completed

CT.gov ID

NCT05648318

Collaborator

(none)

255

Enrollment

Location

Arms

8.1

Actual Duration (Months)

31.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Drug: Lactulose oral solution Drug: PEG	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

255 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

1L Oral Lactulose is an Effective Regimen for Bowel Preparation in Low-risk Patients

Actual Study Start Date :

Jan 8, 2022

Actual Primary Completion Date :

Sep 12, 2022

Actual Study Completion Date :

Sep 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactulose oral solution (LOS)	Drug: 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.
Active Comparator: polyethylene glycol (PEG)	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

Arm

Intervention/Treatment

Experimental: Lactulose oral solution (LOS)

Drug: 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.

Active Comparator: polyethylene glycol (PEG)

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

Outcome Measures

Primary Outcome Measures

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

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]
Cecal intubation rate [1hour]
insertion time [1hour]
withdrawal time [1hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hangzhou first people's Hospital	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Zhang Xiaofeng,MD

Investigators

Principal Investigator: Xiaofeng Zhang, MD, First People's Hospital of Hangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhang Xiaofeng,MD, chief physician, First People's Hospital of Hangzhou

ClinicalTrials.gov Identifier:

NCT05648318

Other Study ID Numbers:

20211206301

First Posted:

Dec 13, 2022

Last Update Posted:

Dec 13, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhang Xiaofeng,MD, chief physician, First People's Hospital of Hangzhou

colonoscopy

bowel preparation

Additional relevant MeSH terms:

Colonic Neoplasms

Lactulose

Study Results

No Results Posted as of Dec 13, 2022