Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.
1. Patients, that come to our clinic with problems caused by a pilonidal sinus are
informed about the different treatment options of the illness.
- 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.
- If the patient has the first time problems by a pilonidal sinus, we recommend an
open limited excision of the fistulas.
- 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.
2. All Patients, that wish their pilonidal sinus 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.
3. Patients, who gave their informed consent for the operation and the study are included.
4. Preoperative data are recorded.
5. The patients are operated on and intraoperative data (e.g. how big was the flap) are
recorded.
6. After 3 Weeks the patients are checked and complications, happiness and duration of the
time off work are recorded.
7. 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
At 1 year all patients were assessed. Patients with a recurrence of a pilonidal sinus were counted. The result is given as number of patients suffering from a recurrence.
1 year
No
Lukas Marti, M D
Principal Investigator
Department of surgery, Cantonal hospital of St. Gallen
Switzerland: Ethikkommission
EKSG 07/050/2B
NCT00672555
August 2006
September 2009
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