Surgical Approach for Pilonidal Disease

Completed

• Conditions: Pilonidal Disease
• Interventions: Procedure: Un-roofing curettage method; Procedure: Modified Limberg Flap Group

• Registration Number: NCT04334681
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study First Submitted: 2020-04-01
• Study Start: 2020-04-02
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Primary Completion: 2020-09-15
• Study Completion: 2020-10-01
• Results First Submitted: 2020-10-02
• Results First Submitted QC: 2021-01-14
• Results First Posted: 2021-02-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC Group	Un-roofing curettage method	Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.
LF Group	Modified Limberg Flap 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.

Primary Outcome Measures

Name	Time	Method
Hospitalization Time	Hospitalization time, up to 15 days	In both groups, hospitalization will be determined as a day.
Mobilization Time,Days	15 days	Time to return to the daily activities of the patients were measured.
Number of Participants With Recurring Disease	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	operation time, up to 100 minutes	Mean operation time was determined in minutes in both groups.

Trial Locations

Locations (1)

Konya Training and Research Hospital; 🇹🇷 Konya, Turkey