PausedTreatment Study

Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

For Condition: Hemorrhoids

ID: NCT03036111

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken

Diet & Lifestyle / Therapy Care

Expected Availability Horizon

Halted (Ended Early)

StageThis study has ended early, been suspended, or was withdrawn. Active evaluation under this trial is currently halted.

EligibleThis study is looking exclusively for patients diagnosed with the condition.

About This Clinical Trial

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.

Read Full Scientific Objectives & Methods

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 & Quick Facts

Trial Status

Temporarily Paused

Total Target Enrollment

42 patients (Estimated)

Study Start Date

2017-02-01

Est. Primary Completion

2018-02-01

Tested Drugs & Treatment Groups

DRUGTrimebutine

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

PROCEDUREHemorrhoidectomy

Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

Treatment Arms Description

SHAM_COMPARATORHemorrhoidectomy

Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before

ACTIVE_COMPARATORtrimebutine

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.

Can I Join This Study?

Suitable For

Everyone welcome

Ages Welcome

Between 18 Years and 70 Years

Full Criteria Checklist

Who Can Join

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

Who Cannot Join

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.

What is this Study Measuring?

Primary Outcome Measures

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

Where to Participate

This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 1 Facilities & Contact Sites

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Trial Design & Scientific Setup

Allocation

randomized

Intervention Model

parallel

Primary Purpose

treatment

Masking

triple (participant, care_provider, outcomes_assessor)

Sponsoring Teams & Contacts

Lead Sponsoring Institution

Mansoura University

Clinical Trial Application Copilot

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Diagnosed Condition

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Subject: Inquiry about clinical trial enrollment: NCT03036111 - Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Dear Study Coordinator / Research Team, I hope this message finds you well. My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "Effect of Topical Trimebutine on Pain After Hemorrhoidectomy" (NCT ID: NCT03036111). I am [Age] years old and have been diagnosed with Hemorrhoids. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate. Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening? Thank you for your time and research efforts. Warm regards, [Your Name]

View Official Medical/Scientific Title

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