NCT03765086

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

July 11, 2018

Last Update Submit

February 2, 2019

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of weeks in which the operative wound will be healed

    4 to 6 weeks

  • percentage of patients developing postoperative pain

    3 days

Study Arms (2)

Karydakis procedure

ACTIVE COMPARATOR

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

Limberg Flap

ACTIVE COMPARATOR

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

Interventions

Karydakis procedurePROCEDURE

Pilonidal sinus will be excised by Karydakis procedure

Karydakis procedure
Limberg FlapPROCEDURE

Pilonidal sinus will be excised by Limberg Flap

Limberg Flap

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pilonidal sinus of any sex and aged 20 years or above
  • Non infected pilonidal sinus

You may not qualify if:

  • Infected pilonidal sinus
  • Uncontrolled diabetes
  • Patient on immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Officer

Study Record Dates

First Submitted

July 11, 2018

First Posted

December 5, 2018

Study Start

August 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

PA(1)