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Clinical Trials/NCT00672555
NCT00672555
Completed
Not Applicable

Prospective Evaluation of Feasibility and Results of the Treatment of Pilonidal Sinus by Excision and Covering of the Defect With a Limberg-flap.

Cantonal Hospital of St. Gallen2 sites in 1 country70 target enrollmentAugust 2006
ConditionsPilonidal Sinus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pilonidal Sinus
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
70
Locations
2
Primary Endpoint
Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
Status
Completed
Last Updated
14 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
September 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure

Time Frame: 1 year

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.

Secondary Outcomes

  • Cosmetic Score(1 year)
  • Body Image Score(1 year)
  • Reoperations Needed for Treatment of Complication(1year)
  • Minor Complications (Wound Complications)(1 year)
  • Patient Overall Satisfaction With Procedure(1 year)

Study Sites (2)

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