Limberg-flap: Prospective Data Collection

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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

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Pilonidal Sinus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pilonidal Sinus T. With Limberg F.

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.

Group Type EXPERIMENTAL

Limberg-flap

Intervention Type PROCEDURE

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

Interventions

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Limberg-flap

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

Intervention Type PROCEDURE

Other Intervention Names

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Romboid-flap

Eligibility Criteria

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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