Limberg-flap: Prospective Data Collection

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672555
• Other study ID #: EKSG 07/050/2B
• Status: Completed
• Phase: N/A
• First received: May 1, 2008
• Last updated: June 3, 2011
• Start date: August 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of sugery, Cantonal hospital of St. Gallen	Rorschach	St. Gallen
Switzerland	Department of surgery, Cantonal hospital of St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Dunker MS, Stiggelbout AM, van Hogezand RA, Ringers J, Griffioen G, Bemelman WA. Cosmesis and body image after laparoscopic-assisted and open ileocolic resection for Crohn's disease. Surg Endosc. 1998 Nov;12(11):1334-40. — View Citation

Kapp T, Zadnikar M, Hahnloser D, Soll Ch, Hetzer FH. [New concept in the treatment of the pilonidal sinus]. Praxis (Bern 1994). 2007 Aug 2;96(31-32):1171-6. Review. German. — View Citation

Müller K, Marti L, Tarantino I, Jayne DG, Wolff K, Hetzer FH. Prospective analysis of cosmesis, morbidity, and patient satisfaction following Limberg flap for the treatment of sacrococcygeal pilonidal sinus. Dis Colon Rectum. 2011 Apr;54(4):487-94. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure	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.	1 year	No
Secondary	Minor Complications (Wound Complications)	All wound complications were assessed; part of them being only very minor dehiscences or slight infections. They were assessed in the outpatients clinic at 3 Weeks and in the follow-up control initiated at 1 year. All patients suffering from a wound complication that occurred in the first year were counted.	1 year	Yes
Secondary	Reoperations Needed for Treatment of Complication	All patients were seen at the outpatients clinic at 3 weeks. Follow-up control was initiated at 1 year.; All reoperations that were done were assessed and measured.	1year	Yes
Secondary	Patient Overall Satisfaction With Procedure	Follow-up was initiated at 1 year. A postal questionnaire was sent to the patients with a VAS assessing overall satisfaction. Possible values were: lowest: 0; highest 10.	1 year	No
Secondary	Body Image Score	Patients was sent a postal questionnaire at 1 year, assessing body image with the body image questionnaire adapted from Dunker et al. Body image score resulting form 5 questions: worst 5; best 20.	1 year	No
Secondary	Cosmetic Score	Patients was sent a postal questionnaire at 1 year, assessing cosmesis with the body image questionnaire adapted from Dunker et al. Cosmetic score resulting form 3 questions: worst 3; best 24.	1 year	No

External Links

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