Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Recurrent Pilonidal Sinus Disease Clinical Trial

Official title:

Effectiveness of Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287935
• Other study ID #: AdanaNTRH
• Status: Completed
• Phase: N/A
• First received: October 24, 2014
• Last updated: November 7, 2014
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Adana Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Adana Training and Research Hospital
• Study type: Interventional

Clinical Trial Summary

It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Description:

Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.

It was investigated whether there is a factor that can aid determination of the preferred technique by comparing the early Limberg flap and Karydakis procedure techniques for the treatment of recurrent pilonidal sinus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patients willing to give written informed consent

2. There should be recurrent pilonidal sinus

2. Recurrent adult patients (over 18 years of age) undergoing surgery for pilonidal sinus

3. International normalizing ratio (INR) less than 1.5

4. Prothrombin time (PT) should be less than 15 s

5. Partial thromboplastin (PTT) time should be near normal

6. Platelet count should be greater than 50,000 per mm3 to limit the risk of bleeding

7. There must be no infection at the time of surgery

Exclusion Criteria:

1. Patients not willing to give informed consent

2. Age less than 16 years

3. Patient presenting with conditions mimicking pilonidal sinus

4. Diabetes mellitus, renal failure, immunosuppression e.g. were excluded

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus
• Recurrent Pilonidal Sinus Disease

Intervention

Procedure:
• Limberg flap
Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
• Karydakis procedure
Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adana Numune Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of Limberg Flap in Recurrent Pilonidal Sinus Disease	Superiority as measured by rates of recurrence and complication, length of hospital stay, return work, VAS skore, patient satisfaction and complet healing duration.	January 2009 to December 2013, Patients were invited for control 1 month, 3 months, 6 months, 1 year intervals	Yes