Randomized Trial on the Effect of Topical Phenytoin on He... | NCT03096522

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

NCT03096522

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Mar 31, 2017Actual

Enrollment

38Estimated

Phase

Not Applicable

Conditions

Anal Fistula

Interventions

Phenytoin 2% spray
Anal fistulotomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2017Actual

Primary Completion Date

Jan 31, 2018Estimated

Completion Date

Mar 30, 2018Estimated

First Submitted Date

Mar 26, 2017

First Submission Date that Met QC Criteria

Mar 26, 2017

First Posted Date

Mar 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2017

Last Update Posted Date

Mar 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phenytoin 2% spray	Active Comparator	Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy	Drug: Phenytoin 2% spray Procedure: Anal fistulotomy
Anal fistulotomy	Active Comparator	Patients undergoing anal fistulotomy without postoperative topical therapy	Procedure: Anal fistulotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phenytoin 2% spray	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing	Complete epithelilization of the fistulotomy wound without persistent external openings or discharge	4-8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sameh Emile, M.D.	Contact			sameh200@hotmail.com

Overall Officials

Name	Affiliation	Role
Sameh H Emile, M.D.	Mansoura University, Faculty of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university hospital	Recruiting	Al Mansurah	Dakahlia Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012003	Rectal Fistula

Ancestor Terms

ID	Term
D007412	Intestinal Fistula
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010672	Phenytoin

Ancestor Terms

ID	Term
D006827	Hydantoins
D048289	Imidazolidines
D007093	Imidazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided