The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

October 4, 2020 updated by: Shengliang Chen, RenJi Hospital
Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200001
        • Recruiting
        • Shengliang Chen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 years patients scheduled for colonoscopy

Exclusion Criteria:

  • intestinal obstruction or hemorrhage;
  • allergy to domperidone, sulpiride or PEG;
  • pregnancy or breastfeeding;
  • previous use of prokinetics within 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Domperidone group
Patients in Domperidone group took 10mg of domperidone 30min before PEG.
Drug: Domperidone
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
Experimental: Sulpiride group
Patients in Sulpiride group took 100mg of sulpiride 30min before PEG.
Drug: sulpiride
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
No Intervention: Control group
Patients in Control group followed the regular routine of 3L split-dose of PEG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the discomforts during bowel preparation
Time Frame: before colonoscopy
The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts.
before colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of bowel preparation assessed by Boston Bowel Preparation Scale
Time Frame: during colonoscopy
The secondary endpoint was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS) during the withdrawal phase of colonoscopy. The BBPS uses a 0-3 points scale assessing the bowel preparation quality in 3 segments of the colon (the right, transverse and left colons). BBPS score ≥ 6 were defined as adequate bowel preparation.
during colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

October 4, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJYYXHNK-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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