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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

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.

Condition or disease Intervention/treatment Phase
Anal Fistula Drug: Phenytoin 2% spray Procedure: Anal fistulotomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Active Comparator: Phenytoin 2% spray
Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
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

Active Comparator: Anal fistulotomy
Patients undergoing anal fistulotomy without postoperative topical therapy
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




Primary Outcome Measures :
  1. Healing [ Time Frame: 4-8 weeks ]
    Complete epithelilization of the fistulotomy wound without persistent external openings or discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03096522


Contacts
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Contact: Sameh Emile, M.D. sameh200@hotmail.com

Locations
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Egypt
Mansoura university hospital Recruiting
Mansoura, Dakahlia, Egypt
Contact: Sameh Emile, M.D       sameh200@hotmail.com   
Sub-Investigator: Ali Sanad, MBBCh         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh H Emile, M.D. Mansoura University, Faculty of medicine

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Responsible Party: Sameh Emile, Principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03096522     History of Changes
Other Study ID Numbers: mansoura33
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Phenytoin
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers