N/A
Completed N=70
Limberg-flap: Prospective Data Collection
Pilonidal Sinus
Source: ClinicalTrials.gov NCT00672555 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure — 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure |
1 | — |
| SECONDARY Minor Complications (Wound Complications) |
18 | — |
| SECONDARY Reoperations Needed for Treatment of Complication |
6 | — |
| SECONDARY Patient Overall Satisfaction With Procedure |
7.6 | — |
| SECONDARY Body Image Score |
17.9 | — |
| SECONDARY Cosmetic Score |
16.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00672555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.