Anal FistulaNCT03096522
Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy
A study testing Phenytoin 2% spray and Anal fistulotomy in people with Anal Fistula, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Phenytoin 2% spray and Anal fistulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sameh Emile, M.D. contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university hospital
Al Mansurah, Dakahlia Governorate
Sameh Emile, M.D, sameh200@hotmail.com
Ali Sanad, MBBCh
About this study
Official title: A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
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.
Read the 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.
- Conditions
- Anal Fistula
- Being tested
- Phenytoin 2% spray, Anal fistulotomy
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenytoin 2% sprayDrug
Also called Healosol
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 fistulotomyProcedure or surgery
Also called Lay open of anal fistula tract
Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base
| Study group | Role | What they receive |
|---|---|---|
| Phenytoin 2% spray | Active comparator | Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy Receives: Drug: Phenytoin 2% spray; Procedure: Anal fistulotomy |
| Anal fistulotomy | Active comparator | Patients undergoing anal fistulotomy without postoperative topical therapy Receives: Procedure: Anal fistulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start20 Feb 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096522
- Sponsor's protocol ID
- mansoura33
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy
- ClinicalTrials.gov ID
- NCT03096522
- Acronym / sponsor ID
- mansoura33
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenytoin 2% spray | Active comparator | Drug: Phenytoin 2% spray, Procedure: Anal fistulotomyPatients undergoing anal fistulotomy with postoperative topical phenytoin therapy |
| Anal fistulotomy | Active comparator | Procedure: Anal fistulotomyPatients undergoing anal fistulotomy without postoperative topical therapy |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenytoin 2% sprayAlso: HealosolPatients 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 | Drug | Phenytoin 2% spray |
| Anal fistulotomyAlso: Lay open of anal fistula tractProbing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base | Procedure or surgery | Anal fistulotomy, Phenytoin 2% spray |
Primary outcome
Healing
Time frame: 4-8 weeks
Complete epithelilization of the fistulotomy wound without persistent external openings or discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh Emile, M.D. contact
Sameh H Emile, M.D. principal investigator
Mansoura University, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenytoin 2% spray and Anal fistulotomy in people with Anal Fistula, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh Emile, M.D. (sameh200@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.