Limberg-Flap: Prospective Datacollection - Full Text View

Purpose

We think, that the treatment of Sinus pilonidalis with excision and covering of the defect with a Limberg-flap is a very good treatment option. We are introducing this treatment for recurrences of this illness in our clinic and want to analyse the feasibility, the results, the complications and the patients opinion after the treatment.

If the results are good, a prospective randomised study is a further option.

Condition	Intervention
Pilonidal Sinus	Procedure: Limberg-flap

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Prospective Evaluation of Feasibility and Results of the Treatment of Sinus Pilonidalis by Excision and Covering of the Defect With a Limberg-Flap.

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:

recurrence rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity: complications, duration of hospital stay, time off work. [ Time Frame: 4 weeks, 1 year ] [ Designated as safety issue: Yes ]
Patients opinion: happy with the operation?; body image? [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental All patients treated by excision and covering of the defect by a Limberg-flap, who gave their informed consent to participate in the study, as there is only one study group.	Procedure: Limberg-flap Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock

Detailed Description:

Patients, that come to our clinic with problems caused by a Sinus pilonidalis are informed about the different treatment options of the illness.
1. If the patient suffers of a recurrence of the illness, a complete excision, followed by a covering of the defect with a Limberg-flap is recommended.
2. If the patient has the first time problems by a Sinus pilonidalis, we recommend an open limited excision of the fistulas.
3. In cases with acute infected situation, we first conduct a very limited incision/excision and treat them with antibiotics. The treatments mentioned before are in such cases offered 3 to 4 Weeks after the fist little operation.
All Patients, that wish their Sinus pilonidalis treated with a complete excision followed by a covering of the defect with a Limberg-flap, are asked if they are willing to participate in the observational study.
Patients, who gave their informed consent for the operation and the study are included.
Preoperative data are recorded.
The patients are operated on and intraoperative data (e.g. how big was the flap) are recorded.
After 4 Weeks the patients are checked and complications, happiness and duration of the time off work are recorded.
After a year the patients are contacted by sending them a postal questionnaire, which they send back to us. Additionally the are contacted by phone. Recurrence, other complications and their opinion concerning the treatment and its consequences are recorded.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recurrence or persistence of a pilonidal sinus
Elective Limberg-flap operation
Written informed consent of the patient for the operation and participation of the study

Exclusion Criteria:

Doubts of the capability of the patient to understand the study or to decide.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672555

Contacts


Contact: Lukas Marti, M D	41-71-858-1535 ext 0041 71	lukas.marti@kssg.ch

Contact: Franc H Hetzer, M D	41-71-494-1339 ext 0041 71	franc.hetzer@kssg.ch

Locations


Switzerland
	Department of surgery, Cantonal hospital of St. Gallen	Recruiting
	St. Gallen, Switzerland, 9007
	Contact: Lukas Marti, M D 41-71-858-1535 ext 0041 71 lukas.marti@kssg.ch
	Contact: Franc H Hetzer, M D 41-71-494-1339 ext 0041 71 franc.hetzer@kssg.ch
	Principal Investigator: Lukas Marti, M D
	Sub-Investigator: Kathrin Müller, -

Switzerland, St. Gallen
	Department of sugery, Cantonal hospital of St. Gallen	Recruiting
	Rorschach, St. Gallen, Switzerland, 9400
	Contact: Lukas Marti, M D 41-71-858-1535 ext 0041 71 lukas.marti@kssg.ch
	Contact: Franc H Hetzer, M D 41-71-494-1339 ext 0041 71 franc.hetzer@kssg.ch
	Principal Investigator: Lukas Marti, M D
	Sub-Investigator: Kathrin Müller, -

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Investigators


Principal Investigator:	Lukas Marti, M D	Department of surgery, Cantonal hospital of St. Gallen

Study Chair:	Franc H Hetzer, M D	Department of surgery, Cantonal hospital of St. Gallen

More Information

Website of our clinic This link exits the ClinicalTrials.gov site

Publications:

Kapp T, Zadnikar M, Hahnloser D, Soll Ch, Hetzer FH. [New concept in the treatment of the pilonidal sinus] Schweiz Rundsch Med Prax. 2007 Aug 2;96(31-32):1171-6. Review. German.

Responsible Party:	Cantonal Hospital of St. Gallen ( Dr. med. D. Germann; (MD) )
Study ID Numbers:	EKSG 07/050/2B
First Received:	May 1, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00672555
Health Authority:	Switzerland: Ethikkommision

Keywords provided by Cantonal Hospital of St. Gallen:

pilonidal sinus

recurrence

Limberg flap

Study placed in the following topic categories:

Pilonidal Sinus

Cysts

Recurrence

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Cantonal Hospital of St. Gallen
Information provided by:	Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT00672555