Clinical Trials Directory

Trials / Completed

CompletedNCT00672555

Limberg-flap: Prospective Data Collection

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Cantonal Hospital of St. Gallen · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURELimberg-flapComplete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock

Timeline

Start date
2006-08-01
Primary completion
2009-01-01
Completion
2009-09-01
First posted
2008-05-06
Last updated
2011-06-29
Results posted
2011-06-29

Locations

2 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT00672555. Inclusion in this directory is not an endorsement.