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NCT03765086 Clinical Trial

Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

Pilonidal Sinus Clinical Trial

Official title:
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03765086
Other study ID # s7
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date July 1, 2018

Study information
Verified date February 2019
Source Services Hospital, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients with pilonidal sinus of any sex and aged 20 years or above

- Non infected pilonidal sinus

Exclusion Criteria:

- Infected pilonidal sinus

- Uncontrolled diabetes

- Patient on immunosuppressive therapy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Karydakis procedure
Pilonidal sinus will be excised by Karydakis procedure
• Limberg Flap
Pilonidal sinus will be excised by Limberg Flap

Locations
Country Name City State
Pakistan Services hospital Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients presenting with recurrence of pilonidal sinus Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure 8 to 12 weeks
Secondary Number of weeks in which the operative wound will be healed Duration of wound healing (complete epithelization of wound ) 4 to 6 weeks
Secondary percentage of patients developing postoperative pain postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery 3 days
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