Clinical trial · Observational
Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus
Importance of Erroneous Off-midline Closure as a Recurrence Factor in Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Sinus: a Multicenter, Matched-case-control Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erroneous off-midline closures | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Recurrent Group
- description
- Patients with clinically confirmed recurrence of sacrococcygeal pilonidal sinus following Limberg flap surgery were eligible (recurrent group, RG). They were evaluated for erroneous off-midline closures as an exposure variable.
- interventionNames
- Procedure: erroneous off-midline closures
- label
- Nonrecurrent Group
- description
- Patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible. They were evaluated for erroneous off-midline closures as an exposure variable.
- interventionNames
- Procedure: erroneous off-midline closures
Primary outcomes (1)
- measure
- erroneous off-midline closures
- timeFrame
- within 1 mont after last patient included to the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (0)
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