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

NCT ID: NCT03096522

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Phenytoin 2% spray

Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy

Group Type ACTIVE_COMPARATOR

Phenytoin 2% spray

Intervention Type DRUG

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

Anal fistulotomy

Intervention Type PROCEDURE

Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base

Anal fistulotomy

Patients undergoing anal fistulotomy without postoperative topical therapy

Group Type ACTIVE_COMPARATOR

Anal fistulotomy

Intervention Type PROCEDURE

Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base

Interventions

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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

Intervention Type DRUG

Anal fistulotomy

Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base

Intervention Type PROCEDURE

Other Intervention Names

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Healosol Lay open of anal fistula tract

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Faculty of medicine

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sameh Emile, M.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sameh Emile, M.D

Role: primary

Other Identifiers

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mansoura33

Identifier Type: -

Identifier Source: org_study_id