Surgical Approach for Pilonidal Disease

Overview

In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients will be divided into two groups as Un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Operation time, hospital stay time, return to work time, recovery time, Time to walk without pain, days, Time to sit on the toilet without pain, days, Postoperative VAS and recurrence will be compared between both groups

Full Title of Study: “Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 15, 2020

Detailed Description

In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients who are well followed up will be included in the study. Demographic features will be recorded. Patients will be divided into two groups, the un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Surgery time, hospital stay, return to work time, recovery time, painless walking time, days, painless sitting time in the toilet, days, postoperative VAS, and recurrence will be compared between both groups. In addition, mobilization time, days, recovery time, days, exclusion time, days, wound infection, wound distribution will be compared between groups. The results will be analyzed with the SPSS statistics program. Factors affecting recurrence wound infection, recovery time, hospital stay, operation time, early mobilization will be evaluated by univariate and multivariate logistic regression analysis.

Interventions

  • Procedure: Un-roofing curettage method
    • In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis.
  • Procedure: Modified Limberg Flap Group
    • In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.

Arms, Groups and Cohorts

  • UC Group
    • Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.
  • LF Group
    • Patients who have been operated with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group.

Clinical Trial Outcome Measures

Primary Measures

  • Mobilization Time,Days
    • Time Frame: 15 days
    • Time to return to the daily activities of the patients were measured.
  • Number of Participants With Recurring Disease
    • Time Frame: Number of Participants with Recurring Disease, up to five years
    • It has been reported in the literature that a five or ten year follow-up period is required for the effective evaluation of recurrence. In both groups, the number of recurrent patients during the follow-up period will be determined. Observation of the following findings on physical examination made a diagnosis of recurrence; New sinus orifice formation, Or discharge from the sinus orifice
  • Operation Time
    • Time Frame: operation time, up to 100 minutes
    • Mean operation time was determined in minutes in both groups.
  • Hospitalization Time
    • Time Frame: Hospitalization time, up to 15 days
    • In both groups, hospitalization will be determined as a day.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients between the ages of 18 and 70 – Patients with sufficient registration information – Telephone-accessible patients Exclusion Criteria:

  • Patients under the age of 18 – Patients over 70 years old – Common gluteal disease – Diabetes mellitus – Connective tissue disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Konya Meram State Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alpaslan Şahin, principal investigator – Konya Meram State Hospital
  • Overall Official(s)
    • Kemal Arslan, MD, Study Chair, Konya Research and Training Hospital

References

Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after excision. Dis Colon Rectum. 2008 Dec;51(12):1816-22. doi: 10.1007/s10350-008-9436-8. Epub 2008 Oct 21.

Kepenekci I, Demirkan A, Celasin H, Gecim IE. Unroofing and curettage for the treatment of acute and chronic pilonidal disease. World J Surg. 2010 Jan;34(1):153-7. doi: 10.1007/s00268-009-0245-6.

Karakayali F, Karagulle E, Karabulut Z, Oksuz E, Moray G, Haberal M. Unroofing and marsupialization vs. rhomboid excision and Limberg flap in pilonidal disease: a prospective, randomized, clinical trial. Dis Colon Rectum. 2009 Mar;52(3):496-502. doi: 10.1007/DCR.0b013e31819a3ec0.

Citations Reporting on Results

Sahin A, Simsek G, Arslan K. Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study. Dis Colon Rectum. 2022 Oct 1;65(10):1241-1250. doi: 10.1097/DCR.0000000000002227. Epub 2022 May 24.

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