Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Bowel Preparation

Intervention / Treatment
-----------------
* Drug: standard preparation (2L PEG-ELS)
* Drug: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)
* Drug: high-volume preparation (4L PEG-ELS)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GroupA：standard preparation<br>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)<br>* Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.<br>|
| Experimental: Group B:low-volume preparation<br>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)<br>* 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.<br>|
| Experimental: Group C：high-volume preparation<br>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)<br>* 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)<br>|

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. | 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 | 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. | 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. | Polyp detection rate was defined as the proportion of patients with at least one polyp. | 6 months | 
| Withdrawal time among 3 groups. | Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps. | 6 months | 
| Caecal intubation rate among 3 groups. | Caecal intubation rate is defined the proportion of patients with caecal intubation. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel preparation, bisacodyl, polyethyleneglycol, colorectal surgery