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Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy

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ClinicalTrials.gov Identifier: NCT03096522
Recruitment Status : Unknown
Verified March 2017 by Sameh Emile, Mansoura University.
Recruitment status was:  Recruiting
First Posted : March 30, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Tracking Information
First Submitted Date  ICMJE March 26, 2017
First Posted Date  ICMJE March 30, 2017
Last Update Posted Date March 31, 2017
Actual Study Start Date  ICMJE February 20, 2017
Estimated Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2017)
Healing [ Time Frame: 4-8 weeks ]
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03096522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
Official Title  ICMJE A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anal Fistula
Intervention  ICMJE
  • Drug: Phenytoin 2% spray
    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
    Other Name: Healosol
  • Procedure: Anal fistulotomy
    Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base
    Other Name: Lay open of anal fistula tract
Study Arms  ICMJE
  • Active Comparator: Phenytoin 2% spray
    Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
    Interventions:
    • Drug: Phenytoin 2% spray
    • Procedure: Anal fistulotomy
  • Active Comparator: Anal fistulotomy
    Patients undergoing anal fistulotomy without postoperative topical therapy
    Intervention: Procedure: Anal fistulotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 26, 2017)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2018
Estimated Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03096522
Other Study ID Numbers  ICMJE mansoura33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sameh Emile, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh H Emile, M.D. Mansoura University, Faculty of medicine
PRS Account Mansoura University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP