Clinical trial NCT04334681: Surgical Approach for Pilonidal Disease
Official title: Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Disease
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Limberg flap after rhomboid excision and un-roofing curettage between January 2013 and January 2017 in our hospital constitute the study population.

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mobilization Time,Days
timeFrame: 15 days
measure: Number of Participants With Recurring Disease
timeFrame: Number of Participants with Recurring Disease, up to five years
measure: Operation Time
timeFrame: operation time, up to 100 minutes
measure: Hospitalization Time
timeFrame: Hospitalization time, up to 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Training and Research Hospital
Study officials:
affiliation: Konya Research and Training Hospital
name: Kemal Arslan, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.