The Effect of Antiemetics on Bowel Preparation Before Colonoscopy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedOctober 12, 2020
September 1, 2020
2 years
September 22, 2020
October 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of the discomforts during bowel preparation
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 Outcomes (1)
The quality of bowel preparation assessed by Boston Bowel Preparation Scale
during colonoscopy
Study Arms (3)
Domperidone group
EXPERIMENTALPatients in Domperidone group took 10mg of domperidone 30min before PEG.
Sulpiride group
EXPERIMENTALPatients in Sulpiride group took 100mg of sulpiride 30min before PEG.
Control group
NO INTERVENTIONPatients in Control group followed the regular routine of 3L split-dose of PEG.
Interventions
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
Eligibility Criteria
You may qualify if:
- years patients scheduled for colonoscopy
You may not qualify if:
- intestinal obstruction or hemorrhage;
- allergy to domperidone, sulpiride or PEG;
- pregnancy or breastfeeding;
- previous use of prokinetics within 1 month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Shengliang Chen
Shanghai, 200001, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director of the Division of Gastroenterology and Hepatology
Study Record Dates
First Submitted
September 22, 2020
First Posted
October 12, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
October 12, 2020
Record last verified: 2020-09