The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Bowel Preparation Clinical Trial

Official title:

The Effect of Antiemetics on Bowel Preparation Before Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583111
• Other study ID #: RJYYXHNK-006
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2020
• Source: RenJi Hospital
• Contact: Shengliang Chen, Dr
• Phone: 02158752345
• Email: slchenmd[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• Domperidone
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
• sulpiride
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.

Locations

Country	Name	City	State
China	Shengliang Chen	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The quality of bowel preparation assessed by Boston Bowel Preparation Scale	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