NCT02663466

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Medical Park Gaziantep Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pilonidal Sinus
• Recurrence

Interventions

Type	Name	Description
PROCEDURE	erroneous off-midline closures	All patients with pilonidal sinus recurrent disease following Limberg flap reconstruction in the recurrent group were examined by the authors in each study center and high resolution close-up photos of the patients' sacrococcygeal area were taken. These photos were then sent to all authors to asses and reach a collective decision to classify the erroneous off-midline closure technique and precisely measuring the distance between the flap border and the midline in the cleft. Same evaluation method was applied to the patients in nonrecurrent group. Following the completion of the assessments, all digital data of the patients were permanently deleted.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2015-11-01
• First posted: 2016-01-26
• Last updated: 2016-01-26

Locations

1 site across 1 country: Turkey (Türkiye)