Clinical trial NCT02761317: Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery
Official title: Optimal Bowel Preparation Regimen for Patients With With a History of Colorectal Resection Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation
Keywords: bowel preparation
bisacodyl
polyethyleneglycol
colorectal surgery
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference of scores rating by Aronchick Preparation Scale among 3 groups.
timeFrame: 6 months
Secondary outcomes:
measure: Rate of compliance with instructions among 3 groups
timeFrame: 6 months
measure: Willingness to repeat bowel preparation among 3 groups.
timeFrame: 6 months
measure: Polyp detection rate among 3 groups.
timeFrame: 6 months
measure: Withdrawal time among 3 groups.
timeFrame: 6 months
measure: Caecal intubation rate among 3 groups.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: li yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: