Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

May 31, 2016 updated by: Yanqing Li, Shandong University

Optimal Bowel Preparation Regimen for Patients With With a History of Colorectal Resection Before Colonoscopy

The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost. A history of colorectal resection represents an independent predictor for inadequate colon cleansing,hence strategies to improve bowel preparation may be a demanding goal in this subset of patients.

The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L polyethylene glycol electrolyte solution) and high-volume preparation (4L polyethylene glycol electrolyte solution, 4L PEG-ELS) in patients with previous colorectal resection. Then the investigators can select the optimized regimen for patients with colorectal surgery.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology, Qilu Hospital, Shandong University
        • Contact:
        • Principal Investigator:
          • Yanqing Li, PhD. MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adults (18< age<75years) referred for surveillance colonoscopy with a history of colorectal resection for Colorectal cancer (CRC).

Exclusion Criteria:

  • severe comorbidities (e.g. congestive heart failure and severe kidney disease)
  • abdominal and pelvic surgery other than colorectal resection for the cause of CRC.
  • severe colonic stricture or obstructing tumour
  • dysphagia
  • compromised swallowing reflex or mental status
  • significant gastroparesis or gastric outlet obstruction
  • known or suspected bowel obstruction or perforation
  • severe chronic renal failure (creatinine clearance<30 ml/min
  • severe congestive heart failure (New York Heart Association class III or IV)
  • uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
  • inflammatory bowel disease or megacolon
  • dehydration
  • disturbance of electrolytes
  • pregnancy or lactation
  • haemodynamically unstable
  • unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GroupA：standard preparation
Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
Drug: standard preparation (2L PEG-ELS)
Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
Experimental: Group B:low-volume preparation
Subjects who are randomized into group B receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. ( 2L PEG-ELS and 10mg bisacodyl )
Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)
Subjects who are randomized into group B will receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure.
Experimental: Group C：high-volume preparation
Subjects who are randomized into group C will receive 2L PEG-ELS at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure. (4 L PEG-ELS)
Drug: high-volume preparation (4L PEG-ELS)
Subjects who are randomized into group C will receive 2L PEG at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure.(4L PEG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of scores rating by Aronchick Preparation Scale among 3 groups.
Time Frame: 6 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of compliance with instructions among 3 groups
Time Frame: 6 months
Compliance was scored on a 3-grade scale based on the intake of bowel solution: 0 = optimal (intake of 100% of the solution); 1 = good (intake of ≥75% of the solution); 2 = poor (intake of <75% of the solution).
6 months
Willingness to repeat bowel preparation among 3 groups.
Time Frame: 6 months
the willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire
6 months
Polyp detection rate among 3 groups.
Time Frame: 6 months
Polyp detection rate was defined as the proportion of patients with at least one polyp.
6 months
Withdrawal time among 3 groups.
Time Frame: 6 months
Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
6 months
Caecal intubation rate among 3 groups.
Time Frame: 6 months
Caecal intubation rate is defined the proportion of patients with caecal intubation.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016SDU-QILU-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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