Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus

Recurrence Clinical Trial

Official title: Importance of Erroneous Off-midline Closure as a Recurrence Factor in Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Sinus: a Multicenter, Matched-case-control Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

Sacrococcygeal Pilonidal sinus (SPS) is a common disorder with estimated incidence of 1.1% in the community and 9% in soldiers. Pilonidal disease is a function of hair x force x vulnerability of the skin, the theory purposed by Karydakis in his article in 1992, and hair follicle obstruction and enlargement, assertion of Bascom are the most widely accepted explanation for etio-pathogenesis of the disease. It is such a disease that, there is still no clear consensus in regard to its gold-standard treatment modality, even though a lot of research and publications.

However, recently off-midline closure techniques has being popularized, by which the suture line is positioned off the midline to ensure minimal chance of recurrence. One of these techniques is the rhomboid, or Limberg, flap (LF) which is widely performed flap surgery for the treatment of SPS in Turkey. However, recurrences can be seen following wide excision and LF reconstruction; therefore, successful implementation of LF technique in the sacrococcygeal area requires well-known characteristics of the flap and problematic anatomy of the gluteal cleft.

There are many reports that favor Limberg flap over others. Although the authors also used to perform LF in patients with SPS with acceptable results until 2008, then they shifted their routine surgical preference to another off-midline closure technique for cosmetic reasons after this date. But increasingly more cases have administered to our institution due to the complications and recurrences after LF which performed elsewhere. Therefore the authors decided to investigate the technical reasons and risk factors of the problem to avoid complications and recurrence related to the incorrect flap design.

The authors first hypothesized that there are an association between erroneous off-midline closures and recurrence in patients underwent LF reconstruction for primary SPS. Then they designed a case-control study to test this hypothesis. ;

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pilonidal Sinus
• Recurrence

• NCT number: NCT02663466
• Study type: Observational
• Source: Medical Park Gaziantep Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Completion date: November 2015