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NCT Number: NCT05648318

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Bowel preparation

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: 1hour

  2. Willingness to repeat bowel preparation

    Time frame: 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

  3. Adenoma detection rate

    Time frame: 7 days

  4. Cecal intubation rate

    Time frame: 1hour

  5. insertion time

    Time frame: 1hour

  6. withdrawal time

    Time frame: 1hour

Sponsors and collaborators

Lead sponsor

Zhang Xiaofeng,MD

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2022
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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