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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01268969
Other study ID # AMRO-1234
Secondary ID
Status Completed
Phase N/A
First received December 29, 2010
Last updated January 3, 2011
Start date February 2008
Est. completion date March 2010

Study information

Verified date February 2008
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- PATINTS WITH PILONIDAL SINUS

Exclusion Criteria:

- PILONIDAL ABSCESS

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. doi: 10.1007/s00268-009-9920-x. — View Citation

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

Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after excision. Dis Colon Rectum. 2008 Dec;51(12):1816-22. doi: 10.1007/s10350-008-9436-8. Epub 2008 Oct 21. — View Citation

Topgül K, Ozdemir E, Kiliç K, Gökbayir H, Ferahköse 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary EARLY COMPLICATIONS , HEALING , EARLY RETURN TO WORK efficacy of the procedures , short and long term patients satisfactions 2 years No
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