Back to resultsRandomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phenytoin 2% spray
Anal fistulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Anal Fistula
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers)
Exclusion Criteria:
- Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas.
- Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.
- Patients under chronic corticosteriod or immunosuppressive therapy.
Sites / Locations
- Mansoura university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Phenytoin 2% spray
Anal fistulotomy
Arm Description
Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
Patients undergoing anal fistulotomy without postoperative topical therapy
Outcomes
Primary Outcome Measures
Healing
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03096522
Brief Title
Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
Official Title
A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Anticipated)
Study Completion Date
March 30, 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
Yes
5. Study Description
Brief Summary
Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.
Detailed Description
Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.
Healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. The two groups will be compared regarding the mean duration till complete healing and postoperative complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phenytoin 2% spray
Arm Type
Active Comparator
Arm Description
Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
Arm Title
Anal fistulotomy
Arm Type
Active Comparator
Arm Description
Patients undergoing anal fistulotomy without postoperative topical therapy
Intervention Type
Drug
Intervention Name(s)
Phenytoin 2% spray
Other Intervention Name(s)
Healosol
Intervention Description
Patients will undergo anal fistulotomy then they will use phenytoin 2% spray topically on the anal wound resulting from fistulotomy with each sitz bath (twice per day) untill the anal wound heals completely
Intervention Type
Procedure
Intervention Name(s)
Anal fistulotomy
Other Intervention Name(s)
Lay open of anal fistula tract
Intervention Description
Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base
Primary Outcome Measure Information:
Title
Healing
Description
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
Time Frame
4-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers)
Exclusion Criteria:
Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas.
Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.
Patients under chronic corticosteriod or immunosuppressive therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh Emile, M.D.
Email
sameh200@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University, Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ali Sanad, MBBCh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
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