NCT02761317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

April 28, 2016

Last Update Submit

May 31, 2016

Conditions

Bowel Preparation

Keywords

bowel preparationbisacodylpolyethyleneglycolcolorectal surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Rate of compliance with instructions among 3 groups

    6 months

  • Willingness to repeat bowel preparation among 3 groups.

    6 months

  • Polyp detection rate among 3 groups.

    6 months

  • Withdrawal time among 3 groups.

    6 months

  • Caecal intubation rate among 3 groups.

    6 months

Study Arms (3)

GroupA：standard preparation

ACTIVE COMPARATOR

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)

Group B:low-volume preparation

EXPERIMENTAL

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)

Group C：high-volume preparation

EXPERIMENTAL

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)

Interventions

standard preparation (2L PEG-ELS)DRUG

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

GroupA：standard preparation
low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)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 B:low-volume preparation
high-volume preparation (4L PEG-ELS)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)

Group C：high-volume preparation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults (18\< age\<75years) referred for surveillance colonoscopy with a history of colorectal resection for Colorectal cancer (CRC).

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Reference StandardsBisacodyl

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative TechniquesCresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • li yanqing, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

li yanqing, PhD,MD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 4, 2016

Study Start

May 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 2, 2016

Record last verified: 2016-05

Locations

CN(1)