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

NCT02663466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2016-01-26

No results posted yet for this study

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.

Conditions

  • Pilonidal Sinus
  • Recurrence

Interventions

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.

Sponsors & Collaborators

  • Medical Park Gaziantep Hospital

    lead OTHER

Principal Investigators

  • Mehmet Kaplan, M.D. · Bahcesehir University Medical School

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02663466 on ClinicalTrials.gov