Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients Wit… (NCT02663466) | Clinical Trial Compass
CompletedNot Applicable
Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus
Turkey (Türkiye)180 participantsStarted 2015-01
Plain-language summary
Background. Limberg flap, one of the recently being popularized off-midline closure techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however, recurrences still can be seen.
Objective. The aim of this study was to assess the relationship between recurrence and off-midline closure errors made in Limberg flap reconstructions.
Design. A multicenter, matched-case-control study was conducted in three participating centers in Turkey.
Settings. Each hospital's database was searched separately and all patients with and without recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were identified.
Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG) were included to the study.
Interventions Main outcome measures. According to the off-midline closure concept, LF reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct closures (type 4, 5 and 6). Then the two groups were analyzed.
Who can participate
Age range
16 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 older than 16 years
* patients had been undergone LF reconstruction for primary SPS with no recurrence at least within the last 5 years
* patients with a clinical diagnosis of disease recurrence following LF surgery performed for primary SPS
* patients or his/her legal representative giving informed consent to make interview and participate to the study.
Exclusion Criteria:
* age younger than 16 years
* patients had been undergone a surgery other than LF for primary SPS
* patients with clinical history of multiple recurrence of the disease after any surgical procedure
* patients who had a recurrence due to the reasons other than correct or erroneous off-midline closure
* patients who had diabetes mellitus, or using steroids, had skin disorders such as hydradenitis suppurativa, had previously received phenol treatment, and patients who refused to give informed consent and who is unavailable or denied to make an interview.
Questions worth asking your doctor
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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?
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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
1
erroneous off-midline closures
Timeframe: within 1 mont after last patient included to the study