Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Bowel Preparation

Treatments: Drug: standard preparation (2L PEG-ELS); Drug: high-volume preparation (4L PEG-ELS); Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02761317

2016SDU-QILU-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

GroupA：standard preparation

Active Comparator group

Description:

Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.

Treatment:

Drug: standard preparation (2L PEG-ELS)

Group B:low-volume preparation

Experimental group

Description:

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 )

Treatment:

Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)

Group C：high-volume preparation

Experimental group

Description:

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)

Treatment:

Drug: high-volume preparation (4L PEG-ELS)