Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02761317
• Other study ID #: 2016SDU-QILU-03
• Status: Recruiting
• Phase: Phase 4
• First received: April 28, 2016
• Last updated: May 31, 2016
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: Shandong University
• Contact: li yanqing, PhD,MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

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.
• 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.
• 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)

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Polyp detection rate among 3 groups.	Polyp detection rate was defined as the proportion of patients with at least one polyp.	6 months	No
Secondary	Withdrawal time among 3 groups.	Withdrawal time from ileocecum, not including the time of treatment and biopsy for polyps.	6 months	No
Secondary	Caecal intubation rate among 3 groups.	Caecal intubation rate is defined the proportion of patients with caecal intubation.	6 months	No