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Completed

NCT Number: NCT04582942

Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification

The purpose of this study is to evaluate the efficacy of polyethylene glycol（PEG） combined with lactulose for bowel preparation before colonoscopy in low-risk patients and high-risk patients.

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Key information

Conditions

Bowel Preparation Before Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

About this study

The quality of bowel preparation is crucial for colonoscopy. Some high-risk factors for inadequate bowel preparation have been identified , including age >70, previous colon surgery, constipation, diabetes, Parkinson's disease, history of stroke or spinal cord injury, prior history of inadequate bowel preparation, body mass index (BMI) >25, use of tricyclic antidepressant or narcotics. Patients were considered as high risk if they have any of the above factors and considered as low risk if they did not have any of these risk factors.This is a multicenter, endoscopist-blinded study to compare the efficacy of PEG combined with lactulose and PEG alone in bowel preparation. In colonoscopy procedures, endoscopists who were blinded to the intervention evaluated the overall quality of colonoscopy cleaning according to the Boston Bowel Preparation Scale. Patients' tolerance, defecation, adverse events and adenoma detection rate (ADR) were also evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults undergoing colonoscopy.

Exclusion criteria

  • 1.presence of any contraindications for colonoscopy (gastrointestinal obstruction or perforation,severe acute inflammatory bowel disease,toxic megacolon,severe heart failure,unable to swallow,severe heart failure,etc);
  • 2.Patients with galactosemia;
  • 3. hypersensitivity to any of the ingredients;
  • 4.Pregnancy or lactation;
  • 5.Use of lactulose,prokinetic agents or purgatives within 7 days;
  • 6.Unwilling to sign informed consent.

Treatment and study plan

PEG

Drug

Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.

Other names: only used PEG

PEG+lactulose

Drug

On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.

Other names: PEG combined with lactulose

Primary outcomes

  1. Boston Bowel Preparation Scale

    Time frame: during colonoscopy

    Cleanliness of the colon during colonoscopy will be evaluated by the Boston Bowel Preparation Scale which is a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. The total BBPS score ranged from 0 to 9. If total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2, we regard it as adequate bowel preparation.

Secondary outcomes

  1. Adenoma Detection Rate

    Time frame: 2 days

    Diagnosis was confirmed by histologic examination

  2. Rate of adverse events

    Time frame: 2 days

    adverse events, such as vomiting, nausea, headache, abdominal distention,abdominal pain.

  3. Cecal intubation rate

    Time frame: during colonoscopy

    Colonoscopy reaches cecal region.

  4. Cecal intubation time

    Time frame: during colonoscopy

    Colonoscopy reaches cecal region.

  5. Withdrawal time

    Time frame: during colonoscopy

    The time from the cecum to the anus, but excluded time for biopsy performance or removal of polyps.

  6. defecation frequency

    Time frame: 2 days

    Frequency of bowel movement.

  7. Willingness to repeat bowel preparation

    Time frame: 2 days

    The number of patients have a willingness to undergo a repeated bowel preparation if needed.

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Hubei Hospital of Traditional Chinese Medicine
  • The General Hospital of Central Theater Command
  • The Third People's Hospital of Hubei Province
  • Tianyou Hospital Affiliated to Wuhan University of Science and Technology
  • Wuhan Central Hospital
  • Wuhan Pu-Ai Hospital
  • Wuhan Puren Hospital
  • Wuhan Red Cross Hospital
  • Wuhan Third Hospital

Registry information

Official study title

Improved Bowel Preparation Method for Colonoscopy Based on Different Risk Stratification：a Multicenter, Endoscopist-blinded Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2020
Registry last updated
Dec 20, 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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