Optimal Bowel Preparation Regimen in Patients With Colorectal Surgery

NCT ID: NCT02761317

Last Updated: 2016-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GroupA：standard preparation

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

Group Type: ACTIVE_COMPARATOR

standard preparation (2L PEG-ELS)

Intervention Type: DRUG

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

Group B:low-volume preparation

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 Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Group C：high-volume preparation

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)

Group Type: EXPERIMENTAL

high-volume preparation (4L PEG-ELS)

Intervention Type: DRUG

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)

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

li yanqing, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

li yanqing, PhD,MD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236 ext. 82169508

Facility Contacts

Yanqing Li, PhD. MD.

Role: primary

qiluliyanqing@gmail.com

86-531-82169236 ext. 82169508

Other Identifiers

2016SDU-QILU-03

Identifier Type: -

Identifier Source: org_study_id