Surgical Approach for Pilonidal Disease

NCT04334681 | Completed Results

• 1 other identifier: pilonidal surgery group
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

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

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (4)

• Mobilization Time,Days

  Time to return to the daily activities of the patients were measured.

  15 days

• 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

• Operation Time

  Mean operation time was determined in minutes in both groups.

  operation time, up to 100 minutes

• Hospitalization Time

  In both groups, hospitalization will be determined as a day.

  Hospitalization time, up to 15 days

Study Arms (2)

UC Group

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

Procedure: Un-roofing curettage method

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.

Procedure: Modified Limberg Flap Group

Interventions

Un-roofing curettage method 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.

UC Group

Modified Limberg Flap Group PROCEDURE

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

LF Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 18937009 BACKGROUND

• 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.

  PMID: 19820992 BACKGROUND

• 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.

  PMID: 19333052 BACKGROUND

• 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.

  PMID: 34840296 RESULT

Results Point of Contact

• Title: Dr. Alpaslan Şahin
• Organization: Principal investigator

drasahin@gmail.com

0332310500

Study Officials

• Kemal Arslan, MD

  Konya Research and Training Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: April 2, 2020
• Primary Completion: September 15, 2020
• Study Completion: October 1, 2020
• Last Updated: October 27, 2022
• Results First Posted: February 8, 2021

Record last verified: 2022-10

Locations

TU (1)