Surgical Approach for Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334681
• Other study ID #: pilonidal surgery group
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2022
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 1, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

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.
• Modified Limberg Flap Group
In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobilization Time,Days	Time to return to the daily activities of the patients were measured.	15 days
Primary	Number of Participants With Recurring Disease	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	Number of Participants with Recurring Disease, up to five years
Primary	Operation Time	Mean operation time was determined in minutes in both groups.	operation time, up to 100 minutes
Primary	Hospitalization Time	In both groups, hospitalization will be determined as a day.	Hospitalization time, up to 15 days