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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02663466
• Date of registration: 18/01/2016
• Prospective Registration: No
• Primary sponsor: Medical Park Gaziantep Hospital
• Public title: Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus
• Scientific title: Importance of Erroneous Off-midline Closure as a Recurrence Factor in Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Sinus: a Multicenter, Matched-case-control Study
• Date of first enrolment: January 2015
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02663466
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Mehmet Kaplan, M.D.
• Affiliation: Bahcesehir University Medical School

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pilonidal Sinus

Recurrence

Intervention(s)

Procedure: erroneous off-midline closures

Primary Outcome(s)

erroneous off-midline closures [Time Frame: within 1 mont after last patient included to the study]

Secondary Outcome(s)

Suture type [Time Frame: within the first month after completion of the patient recruitment]

Safe distance [Time Frame: within 1 month after the last patient included to the study]

Correct off-midline closures [Time Frame: within 1 month after last patient included to the study]

Secondary ID(s)

MK-005-PS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors