Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

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

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Karydakis procedure; Procedure: Limberg Flap

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Karydakis procedure; Karydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline.	Procedure: Karydakis procedure; Pilonidal sinus will be excised by Karydakis procedure
Active Comparator: Limberg Flap; Limberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap.	Procedure: Limberg Flap; Pilonidal sinus will be excised by Limberg Flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of weeks in which the operative wound will be healed	Duration of wound healing (complete epithelization of wound )	4 to 6 weeks
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

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: s7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No