Surgical Treatment of High Perianal Fistulas (NCT01997645) | Clinical Trial Compass
UnknownNot Applicable
Surgical Treatment of High Perianal Fistulas
Czechia140 participantsStarted 2013-11
Plain-language summary
Perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. According to Parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. Simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously.
Therefore sphincter preserving procedures should be preferred in these cases. Rectal advancement mucosal flap (RAF) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. However, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review.
Ligation of the intersphincteric fistula tract (LIFT) has been presented in 2007 as a simple sphincter preserving technique. The success rate varies between 40-95% with low overall incontinence rate (6%).
The aim of the study is to compare the efficacy of the LIFT and RAF procedure for treatment of high perianal fistulas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 years old or older
* Diagnosis of simple intersphincteric or transsphincteric fistula
* Patients able to comply with the study protocol as per investigator criteria
* Signed and dated informed consent by the patient
* Absence of any exclusion criteria
Exclusion Criteria:
* Recurrent anal fistula
* Suprasphincteric, low subcutaneous fistula
* Multiple fistulas
* Posttraumatic fistula
* Perianal hidradenitis
* Fistula arises from other than cryptoglandular origin
* Previous anal surgery except of abscess
* Inflammatory Bowel Disease
* History of fecal incontinence
* Rectal prolapse
* Malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment
* HIV infection
* Pregnancy
* Participation in another clinical trial less than one month prior to enrolment, or involvement in another trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.