CompletedNot Applicable

Modified LIFT Versus Standard LIFT for Transsphincteric Anal Fistula

Turkey (Türkiye)40 participantsStarted 2024-01-01

Plain-language summary

This study evaluated two sphincter-preserving surgical techniques for transsphincteric anal fistula: standard ligation of the intersphincteric fistula tract (LIFT) and modified LIFT via a lateral approach. Adult patients with MRI-confirmed transsphincteric anal fistula were randomly assigned to one of the two procedures. The main outcome was wound healing time. Other outcomes included early recurrence or persistence of the fistula, postoperative pain, and fecal continence during 12 weeks of follow-up.

Who can participate

Age range

18 Years – 75 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: * Age 18 to 75 years * Diagnosis of transsphincteric anal fistula confirmed by pelvic magnetic resonance imaging * Presence of clinical findings consistent with perianal fistula, such as perianal discharge, palpable swelling, or history of perianal abscess drainage * Ability and willingness to provide written informed consent * Eligibility for surgical treatment with either standard LIFT or modified LIFT via a lateral approach Exclusion Criteria: * Previous definitive surgery for perianal fistula other than abscess drainage * Perianal Crohn disease * Horseshoe fistula * Colorectal cancer * Malnutrition * Recurrent anal fistula * Previous radiotherapy or chemotherapy * Chronic medication use that could impair wound healing, such as steroids or colchicine * Refusal or inability to provide written informed consent

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.

What they're measuring

Wound Healing Time

Timeframe: Up to 12 weeks after surgery

Trial details

NCT IDNCT07603635

SponsorTugberk Tok

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-05-01

View on ClinicalTrials.gov More Anal Fistula Surgery trials