Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

NCT ID: NCT03036111

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-04-01

Brief Summary

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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

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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.

Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Hemorrhoidectomy

Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before

Group Type SHAM_COMPARATOR

Hemorrhoidectomy

Intervention Type PROCEDURE

Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

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.

Group Type ACTIVE_COMPARATOR

Trimebutine

Intervention Type DRUG

Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.

Hemorrhoidectomy

Intervention Type PROCEDURE

Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

Interventions

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Trimebutine

Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.

Intervention Type DRUG

Hemorrhoidectomy

Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

Intervention Type PROCEDURE

Other Intervention Names

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Gastreg suppository

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansourau20172

Identifier Type: -

Identifier Source: org_study_id

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