Comparison Between Two Different Technique in Treatment of Chronic Pilonidal Disease - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Plastic and Cosmetic Surgery

U.S. FDA Resources

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

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

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

More Information

Additional Information:

Mansoura university This link exits the ClinicalTrials.gov site

Publications:

Topgül K, Ozdemir E, Kiliç K, Gökbayir H, Ferahkö?e Z. Long-term results of limberg flap procedure for treatment of pilonidal sinus: a report of 200 cases. Dis Colon Rectum. 2003 Nov;46(11):1545-8.

Füzün M, Bakir H, Soylu M, Tansu? T, Kaymak E, Ha?mancio?lu O. Which technique for treatment of pilonidal sinus--open or closed? Dis Colon Rectum. 1994 Nov;37(11):1148-50.

el-Khadrawy O, Hashish M, Ismail K, Shalaby H. Outcome of the rhomboid flap for recurrent pilonidal disease. World J Surg. 2009 May;33(5):1064-8.

Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after excision. Dis Colon Rectum. 2008 Dec;51(12):1816-22. Epub 2008 Oct 21.

Responsible Party:	WALEED ASKAR, mansoura university hospital
ClinicalTrials.gov Identifier:	NCT01268969 History of Changes
Other Study ID Numbers:	AMRO-1234
Study First Received:	December 29, 2010
Last Updated:	January 3, 2011
Health Authority:	Egypt: Institutional Review Board

Keywords provided by Mansoura University:

pilonidal disease PND

ClinicalTrials.gov processed this record on June 18, 2013

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