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Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

This study has suspended participant recruitment.
(Unavailability of Triembutine maleate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT03036111
First Posted: January 30, 2017
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sameh Emile, Mansoura University
  Purpose
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.

Condition Intervention
Hemorrhoids Drug: Trimebutine Procedure: Hemorrhoidectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sameh Emile, Mansoura University:

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


Estimated Enrollment: 42
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: April 1, 2018
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Hemorrhoidectomy
Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
Procedure: Hemorrhoidectomy
Patients will undergo classic Milliagn-Morgan hemorrhoidectomy
Active Comparator: 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.
Drug: Trimebutine
Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
Other Name: Gastreg suppository
Procedure: Hemorrhoidectomy
Patients will undergo classic Milliagn-Morgan hemorrhoidectomy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036111


Locations
Egypt
Mansoura university hospital
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Sameh H Emile, M.D. Mansoura University
  More Information

Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03036111     History of Changes
Other Study ID Numbers: mansourau20172
First Submitted: January 24, 2017
First Posted: January 30, 2017
Last Update Posted: August 29, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Trimebutine
Gastrointestinal Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs