Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Not Applicable

Suspended

• Conditions: Hemorrhoids
• Interventions: Procedure: Hemorrhoidectomy; Drug: Trimebutine

• Registration Number: NCT03036111
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-02-01
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29
• Primary Completion: 2018-02-01
• Study Completion: 2018-04-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemorrhoidectomy	Hemorrhoidectomy	Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
trimebutine	Hemorrhoidectomy	Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.
trimebutine	Trimebutine	Patients will undergo Millgan-Morgan hemorrhoidectomy then triembutine suppository will be inserted in the anal canal intraoperatively and then every six hours for 24 hours.

Primary Outcome Measures

Name	Time	Method
Pain assessment assessed using visual analogue score from 0-10	Pain will be assessed at 12 hours after the procedure	Anal pain will be assessed using visual analogue score from 0-10

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Dakahlia, Egypt