Surgical Approach for Pilonidal Disease

NCT ID: NCT04334681

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 278 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-02
• Study Completion Date: 2020-10-01

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.

Conditions

Pilonidal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

UC Group

Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group.

Un-roofing curettage method

Intervention Type: PROCEDURE

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.

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.

Modified Limberg Flap Group

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya Meram State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alpaslan Şahin

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kemal Arslan, MD

Role: STUDY_CHAIR

Konya Research and Training Hospital

Locations

Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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.

Reference Type: BACKGROUND

PMID: 18937009 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19820992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19333052 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34840296 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

pilonidal surgery group

Identifier Type: -

Identifier Source: org_study_id