Study on Surgical Treatment of Pilonidal Sinus Disease

Comparative Analysis of the Same technique-the Same Surgeon Approach in the Surgical Treatment of Pilonidal Sinus Disease: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: surgery for pilonidal sinus disease

Detailed Description

Pilonidal sinus disease (PSD) is a common chronic disease that generally affects young adults below the age of 45. It is most commonly observed at the inter-gluteal region, though it may also affect other sites like the umbilicus and the inter-digital area, particularly among in barbers. The disease was long thought to be either congenital or acquired; although in recent years it has been more widely viewed as an acquired disease. The etiology of PSD is not fully understood, however, the most important cause is believed to be fallen hairs accumulating within skin folds and implanting within the skin. The skin becomes more prone to maceration, sweating and bacterial contamination, which facilitates implantation of fallen hairs, creating the necessary conditions for development of the disease. Although PSD is a benign disease, it produces symptoms such as pain and discharge, which adversely affect patient quality of life.

There are many approaches for treatment of the disease, including several surgical methods such as limited or large excision, primary closure, or flap techniques, and many other non-surgical methods. However, no consensus has been reached regarding the ideal treatment method. An ideal surgical treatment reduces recurrence and complication rates, and allows for minimal hospitalization and rapid return to daily activities. Among patients treated using the limited excision and primary closure method, the presence of a natal cleft is associated with higher morbidity, resulting in recurrence rates of 7-42%. For techniques that use the flap approach, this rate decreases to 0-3%. In patients undergoing the Rhomboid excision and Limberg flap techniques, which require a larger surgical area compared to the limited excision and primary closure methods, complication rates are lower, and length of hospital-stay and time to return to work are reduced. However, using the classical Limberg flap technique, maceration and scar formation due to sutures in the inter-gluteal sulcus, and the accumulation of hair at the midline may result in recurrence. Application of a modified Limberg technique that includes lateralization of the middle line can help reduce wound complications and recurrence rates. Several publications report contradicting results regarding surgical outcomes using the same technique, which may be attributable to differences in practice between surgeons. Therefore, it can be logical to explore the superiority of any type of surgical technique performed by the same surgeon for the surgical treatment of pilonidal sinus disease.

• Study Type: Observational
• Enrollment (Actual): 802

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 71 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.
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; surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.
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; surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	through study completion at an average of 36 months

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: mustafa hasbahceci, assoc. prof., Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: recurrence; complication; pilonidal sinus
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Cysts; Otorhinolaryngologic Diseases; Nose Diseases; Pilonidal Sinus; Paranasal Sinus Diseases
• Other Study ID Numbers: PilonidalSinus-EK/MH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No