Back to resultsEffect of Topical Trimebutine on Pain After Hemorrhoidectomy
Primary Purpose
Hemorrhoids
Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Trimebutine
Hemorrhoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoids
Eligibility 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.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Hemorrhoidectomy
trimebutine
Arm Description
Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
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.
Outcomes
Primary Outcome Measures
Pain assessment assessed using visual analogue score from 0-10
Anal pain will be assessed using visual analogue score from 0-10
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03036111
Brief Title
Effect of Topical Trimebutine on Pain After Hemorrhoidectomy
Official Title
Effect of Trimebutine on Postoperative Pain After Milligan-Morgan Hemorrhoidectomy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Suspended
Why Stopped
Unavailability of Triembutine maleate
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hemorrhoidectomy
Arm Type
Sham Comparator
Arm Description
Patients will undergo Millgan-Morgan hemorrhoidectomy as classically described before
Arm Title
trimebutine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trimebutine
Other Intervention Name(s)
Gastreg suppository
Intervention Description
Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Hemorrhoidectomy
Intervention Description
Patients will undergo classic Milliagn-Morgan hemorrhoidectomy
Primary Outcome Measure Information:
Title
Pain assessment assessed using visual analogue score from 0-10
Description
Anal pain will be assessed using visual analogue score from 0-10
Time Frame
Pain will be assessed at 12 hours after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Topical Trimebutine on Pain After Hemorrhoidectomy
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