Limberg-flap: Prospective Data Collection

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: Limberg-flap

Study type: Interventional

Funder types: Other

Identifiers

NCT00672555

EKSG 07/050/2B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Pilonidal Sinus T. With Limberg F.

Experimental group

Description:

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.

Treatment:

Procedure: Limberg-flap