NCT01268969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

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

February 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
Last Updated

January 4, 2011

Status Verified

February 1, 2008

Enrollment Period

2.1 years

First QC Date

December 29, 2010

Last Update Submit

January 3, 2011

Conditions

Pilonidal Disease

Keywords

pilonidal disease PND

Outcome Measures

Primary Outcomes (1)

  • EARLY COMPLICATIONS , HEALING , EARLY RETURN TO WORK

    efficacy of the procedures , short and long term patients satisfactions

    2 years

Study Arms (2)

excision and krydakis reconstruction

ACTIVE COMPARATOR

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

surgical excision and limberg closure

ACTIVE COMPARATOR

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

Interventions

KARYDAKIS GROUPPROCEDURE

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

Also known as: GROUP 1
excision and krydakis reconstruction
Lamberg flap techniquePROCEDURE

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

Also known as: group 2
surgical excision and limberg closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PATINTS WITH PILONIDAL SINUS

You may not qualify if:

  • PILONIDAL ABSCESS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Mansoura, Egypt

Location

Related Publications (4)

  • Topgul K, Ozdemir E, Kilic K, Gokbayir H, Ferahkose 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. doi: 10.1007/s10350-004-6811-y.

    PMID: 14605577RESULT

  • Fuzun 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. doi: 10.1007/BF02049819.

    PMID: 7956585RESULT

  • 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.

    PMID: 19198934RESULT

  • 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.

    PMID: 18937009RESULT

Related Links

Study Officials

  • waleed askar, M.D

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2010

First Posted

January 4, 2011

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 4, 2011

Record last verified: 2008-02

Locations

EG(1)