Study on Surgical Treatment of Pilonidal Sinus Disease

NCT02849197 | Completed

• 1 other identifier: PilonidalSinus-EK/MH
• Study Type: observational
• Target: 802
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon, in terms of postoperative outcomes and recurrence rates.

Conditions

Pilonidal Sinus

Keywords

pilonidal sinus; complication; recurrence

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  through study completion at an average of 36 months

Study Arms (3)

Primary Closure

Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: primary closure. Technical details: An elliptical incision was made, and the excision included sinus openings at the median line and extended down to the pre-sacral fascia. One suction drain was placed in the wound cavity. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and skin was closed with interrupted 2-0 silk suture.

Procedure: surgery for pilonidal sinus disease

Limberg Flap Technique

Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: Limberg Flap Technique. Technical details: A rhomboid incision was made as to include all sinus openings, and an excision was made down to the pre-sacral fascia. A bisector drawn in the rhombohedron was extended laterally to a length similar to that of a corner of the rhombohedron. Then, the flap was prepared by removing gluteal muscle with its fascia. One suction drain was placed at the wound cavity. The base of the flap was approximated with the presacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable sutures, and the skin was closed with interrupted 3-0 prolene suture.

Procedure: surgery for pilonidal sinus disease

Modified Limberg Technique

Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: Modified Limberg Flap Technique. Technical details: As in Limberg flap technique, a rhomboid incision was made. Upper and lower corners of the excision were lateralized 2 cm away from the midline in order to keep the suturing line at the inferior from overlapping the midline. An excision was made down to the pre-sacral fascia. One suction drain was placed at the wound cavity, and the base of the flap was approximated with the pre-sacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and the skin was closed with 3-0 prolene.

Procedure: surgery for pilonidal sinus disease

Interventions

surgery for pilonidal sinus disease PROCEDURE

surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.

Limberg Flap Technique; Modified Limberg Technique; Primary Closure

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 1082 patients who were diagnosed with pilonidal sinüs disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015.

You may qualify if:

• patients who were diagnosed with pilonidal sinus disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015

You may not qualify if:

• patients with incomplete personal and medical data and who could not be contacted by direct interview or by telephone

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Pilonidal Sinus; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• mustafa hasbahceci, assoc. prof.

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 29, 2016
• Study Start: January 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share