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Comparison Between Two Different Technique in Treatment of Chronic Pilonidal Disease (PND)

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01268969
First received: December 29, 2010
Last updated: January 3, 2011
Last verified: February 2008
  Purpose

Comparison between limberg flap and Karydakis flap for treatment of pilonidal disease.


Condition Intervention
Pilonidal Disease
Procedure: KARYDAKIS GROUP
Procedure: Lamberg flap technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial-comparing Excision and Limberg Flap Closure Versus Karydakis Flap Reconstruction for Treatment of Sacrococcygeal Pilonidal Disease

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • EARLY COMPLICATIONS , HEALING , EARLY RETURN TO WORK [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    efficacy of the procedures , short and long term patients satisfactions


Enrollment: 120
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: excision and krydakis reconstruction
The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one
Procedure: KARYDAKIS GROUP
The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one
Other Name: GROUP 1
Active Comparator: surgical excision and limberg closure
The area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia . The fasciocutaneous flap was transposed medially so that the defect would be covered without any tension.
Procedure: Lamberg flap technique
The area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia
Other Name: group 2

Detailed Description:

The authors prospectively studied patients with sacrococcygeal pilonidal disease (SPD) at Mansoura University Hospital, Mansoura, Egypt, .Patients were randomly assigned to undergo either Limberg rhomboid flap or Karydakis flap reconstruction . The follow-up period ranged from 8 months to two years, with the mean follow-up period about 18 months. Surgical findings, complications, recurrence rate and degree of patient satisfaction were compared. This a randomized controlled study to evaluate both rhomboid excision and limberg flap closure versus Karydakis flap for treatment of chronic pilonidal disease.

Karydakis flap reconstruction was performed in conformity with the original procedure described by Karydakis. The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one.

Lamberg flap technique: the area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia (Fig3a). The size of the prepared flap was equal to that of the rhomboid area. Meticulous hemostasis was accomplished by electrocauterization. The fasciocutaneous flap was transposed medially so that the defect would be covered without any tension. Sutures were placed between gluteus fascia of the flap and presacral fascia with 2/0 polyglactin to prevent dead space

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PATINTS WITH PILONIDAL SINUS

Exclusion Criteria:

  • PILONIDAL ABSCESS
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01268969

Locations
Egypt
Mansoura University
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: waleed askar, M.D mansoura university hospital