Limberg-flap: Prospective Data Collection

Status Completed

Clinical Trial Summary

The investigators think, that the treatment of pilonidal sinus with excision and covering of the defect with a Limberg-flap is a very good treatment option. The investigators 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Pilonidal Sinus

Clinical Trial Details

NCT number	NCT00672555
Study type	Interventional
Source	Cantonal Hospital of St. Gallen
Contact
Status	Completed
Phase	N/A
Start date	August 2006
Completion date	September 2009

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.