Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

Phase 4

• Conditions: Bowel Preparation
• Interventions: Drug: standard preparation (2L PEG-ELS); Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS); Drug: high-volume preparation (4L PEG-ELS)

• Registration Number: NCT02761317
• Lead Sponsor: Shandong University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-04-28
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-02
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupA：standard preparation	standard preparation (2L PEG-ELS)	Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
Group B:low-volume preparation	low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)	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 )
Group C：high-volume preparation	high-volume preparation (4L PEG-ELS)	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of compliance with instructions among 3 groups	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).
Withdrawal time among 3 groups.	6 months	Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.
Caecal intubation rate among 3 groups.	6 months	Caecal intubation rate is defined the proportion of patients with caecal intubation.
Willingness to repeat bowel preparation among 3 groups.	6 months	the willingness to repeat the same bowel preparation,a patient's subjective evaluation of the bowel preparation was recorded by a questionnaire
Polyp detection rate among 3 groups.	6 months	Polyp detection rate was defined as the proportion of patients with at least one polyp.

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China