Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

NCT03036111 | Suspended

• 1 other identifier: mansourau20172
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hemorrhoidectomy

SHAM COMPARATOR

Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before

Procedure: Hemorrhoidectomy

trimebutine

ACTIVE COMPARATOR

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.

Drug: Trimebutine; Procedure: Hemorrhoidectomy

Interventions

Trimebutine DRUG

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

Also known as: Gastreg suppository

trimebutine

Hemorrhoidectomy PROCEDURE

Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

Hemorrhoidectomy; trimebutine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Trimebutine; Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sameh H Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 30, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 29, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)