Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus

Sacrococcygeal Pilonidal Disease Clinical Trial

Official title:

Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116738
• Other study ID #: GMMA-LEC-001642
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: April 15, 2014
• Start date: June 2013
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: Ankara Mevki Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.

Description:

Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Pilonidal Sinus Disease

• Must be able to suitable for the surgery

Exclusion Criteria:

• Patients with Recurrent Pilonidal Sinus disease

• Patient whom is not suitable for surgery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus
• Sacrococcygeal Pilonidal Disease

Intervention

Procedure:
• Flap Transposition Procedures
Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases

Locations

Country	Name	City	State
Turkey	Ankara Mevki Military Hospital : General Surgery Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Mevki Military Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)		12 hours	Yes

External Links

•   Turkish Surgical Association