Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus

NCT02663466 | Completed DMC

• 1 other identifier: MK-005-PS
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Limberg flap, one of the recently being popularized off-midline closure techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however, recurrences still can be seen. Objective. The aim of this study was to assess the relationship between recurrence and off-midline closure errors made in Limberg flap reconstructions. Design. A multicenter, matched-case-control study was conducted in three participating centers in Turkey. Settings. Each hospital's database was searched separately and all patients with and without recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were identified. Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG) were included to the study. Interventions Main outcome measures. According to the off-midline closure concept, LF reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct closures (type 4, 5 and 6). Then the two groups were analyzed.

Conditions

Pilonidal Sinus; Recurrence

Keywords

pilonidal sinus; Limberg flap; off-midline closure concept; recurrence

Outcome Measures

Primary Outcomes (1)

• erroneous off-midline closures

  Erroneous off-midline closure referred to the incision lines and/or angles of the LF are centered in- and/or crossed the midline or to be closer than 1 cm to the midline of the cleft between the buttocks.

  within 1 mont after last patient included to the study

Secondary Outcomes (3)

• Suture type

  within the first month after completion of the patient recruitment

• Safe distance

  within 1 month after the last patient included to the study

• Correct off-midline closures

  within 1 month after last patient included to the study

Study Arms (2)

Recurrent Group

Patients with clinically confirmed recurrence of sacrococcygeal pilonidal sinus following Limberg flap surgery were eligible (recurrent group, RG). They were evaluated for erroneous off-midline closures as an exposure variable.

Procedure: erroneous off-midline closures

Nonrecurrent Group

Patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible. They were evaluated for erroneous off-midline closures as an exposure variable.

Procedure: erroneous off-midline closures

Interventions

erroneous off-midline closures PROCEDURE

All patients with pilonidal sinus recurrent disease following Limberg flap reconstruction in the recurrent group were examined by the authors in each study center and high resolution close-up photos of the patients' sacrococcygeal area were taken. These photos were then sent to all authors to asses and reach a collective decision to classify the erroneous off-midline closure technique and precisely measuring the distance between the flap border and the midline in the cleft. Same evaluation method was applied to the patients in nonrecurrent group. Following the completion of the assessments, all digital data of the patients were permanently deleted.

Also known as: Rhomboid flap reconstruction

Nonrecurrent Group; Recurrent Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with clinically confirmed recurrence of SPS following LF surgery (recurrent group, RG) and patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible.

You may qualify if:

• age older than 16 years
• patients had been undergone LF reconstruction for primary SPS with no recurrence at least within the last 5 years
• patients with a clinical diagnosis of disease recurrence following LF surgery performed for primary SPS
• patients or his/her legal representative giving informed consent to make interview and participate to the study.

You may not qualify if:

• age younger than 16 years
• patients had been undergone a surgery other than LF for primary SPS
• patients with clinical history of multiple recurrence of the disease after any surgical procedure
• patients who had a recurrence due to the reasons other than correct or erroneous off-midline closure
• patients who had diabetes mellitus, or using steroids, had skin disorders such as hydradenitis suppurativa, had previously received phenol treatment, and patients who refused to give informed consent and who is unavailable or denied to make an interview.

Sponsors & Collaborators

• Medical Park Gaziantep Hospital: lead

Study Sites (1)

Mehmet Kaplan

Gaziantep, Şehitkamil, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pilonidal Sinus; Recurrence

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Kaplan, M.D.

  Bahcesehir University Medical School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 26, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)