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NCT03036111 Clinical Trial

Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:
Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT03036111
Other study ID # mansourau20172
Secondary ID
Status Suspended
Phase N/A
First received January 24, 2017
Last updated August 28, 2017
Start date February 1, 2017
Est. completion date April 1, 2018

Study information
Verified date January 2017
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.

Description:

A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.

Recruitment information / eligibility
Status Suspended
Enrollment 42
Est. completion date April 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included

Exclusion Criteria:

- Patients with grade I/II internal hemorrhoids or external hemorrhoids.

- Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\

- Patients with recurrent hemorrhoids after previous surgery.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trimebutine
Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
Procedure:
• Hemorrhoidectomy
Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

Locations
Country Name City State
Egypt Mansoura university hospital Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain assessment assessed using visual analogue score from 0-10 Anal pain will be assessed using visual analogue score from 0-10 Pain will be assessed at 12 hours after the procedure
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