The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Phase 4

• Conditions: Bowel Preparation
• Interventions: Drug: Domperidone; Drug: sulpiride

• Registration Number: NCT04583111
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-10-04
• Last Update Submitted: 2020-10-04
• Study First Posted: 2020-10-12
• Last Update Posted: 2020-10-12
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Domperidone group	Domperidone	Patients in Domperidone group took 10mg of domperidone 30min before PEG.
Sulpiride group	sulpiride	Patients in Sulpiride group took 100mg of sulpiride 30min before PEG.

Primary Outcome Measures

Name	Time	Method
Incidence of the discomforts during bowel preparation	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.

Secondary Outcome Measures

Name	Time	Method
The quality of bowel preparation assessed by Boston Bowel Preparation Scale	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.

Trial Locations

Locations (1)

Shengliang Chen; 🇨🇳 Shanghai, China