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Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

Primary Purpose

Pilonidal Sinus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Karydakis procedure
Limberg Flap
Sponsored by
Services Hospital, Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Services hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Karydakis procedure

Limberg Flap

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of weeks in which the operative wound will be healed
Duration of wound healing (complete epithelization of wound )
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

Full Information

First Posted
July 11, 2018
Last Updated
February 2, 2019
Sponsor
Services Hospital, Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT03765086
Brief Title
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
Official Title
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Karydakis procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Limberg Flap
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Karydakis procedure
Intervention Description
Pilonidal sinus will be excised by Karydakis procedure
Intervention Type
Procedure
Intervention Name(s)
Limberg Flap
Intervention Description
Pilonidal sinus will be excised by Limberg Flap
Primary Outcome Measure Information:
Title
Percentage of patients presenting with recurrence of pilonidal sinus
Description
Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure
Time Frame
8 to 12 weeks
Secondary Outcome Measure Information:
Title
Number of weeks in which the operative wound will be healed
Description
Duration of wound healing (complete epithelization of wound )
Time Frame
4 to 6 weeks
Title
percentage of patients developing postoperative pain
Description
postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmmood Ayyaz, mbbs, fcps
Organizational Affiliation
Services Hospital, Lahore
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

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