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NCT Number: NCT02998255

Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy

Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG still results in lower compliance to the regime and increased cost.

Some high risk factors for inadequate BP have been identified, including old age, constipation, diabetes, the use of narcotics and prior history of inadequate BP. For average-risk patients without the high risk factors, the procedure of BP could be easier. In the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk patients achieved adequate BP. Here investigators hypothesized that compared with the standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while may be accompanied with better tolerability.

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Key information

Conditions

Health Behavior Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of gastroenterology, Qinghai Provincial People's Hospital, Xining, Qinghai, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing colonoscopy;
  • Patients with average risks for inadequate BP (Patients were identified average-risk if they did not meet any factor of the following risk factors):
  • Constipation
  • Diabetes
  • Parkinson's disease
  • History of stroke or spine cord injure
  • Prior history of inadequate bowel preparation
  • BMI>25
  • Use of tricyclic antidepressant or narcotics

Exclusion criteria

  • History of colorectal resection;
  • Suspected colonic stricture or perforation;
  • Incomplete or complete bowel obstruction;
  • Use of prokinetic agents or purgatives within 7 days;
  • Toxic colitis or megacolon;
  • Pregnancy or lactation;
  • Unable to give informed consent;
  • Haemodynamically unstable.

Treatment and study plan

Single dose of 2L PEG

Drug

Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.

Split dose of 4L PEG

Drug

All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Primary outcomes

  1. Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)

    Time frame: 1 year

    The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), 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. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.

Secondary outcomes

  1. Polyp detection rate

    Time frame: 1 year

  2. Rate of adverse events

    Time frame: 1 year

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

  3. Cecal intubation rate

    Time frame: 1 year

  4. Cecal intubation time

    Time frame: 1 year

  5. Withdrawal time

    Time frame: 1 year

  6. Willingness to repeat bowel preparation

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Sep 13, 2017

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

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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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