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.

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Limberg-flap

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9007
    • Department of surgery, Cantonal hospital of St. Gallen
  • St. Gallen
    • Rorschach, St. Gallen, Switzerland, 9400
      • Department of sugery, Cantonal hospital of St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Limberg-flap; Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock; Other Names: Romboid-flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Lukas Marti, M D, Department of surgery, Cantonal hospital of St. Gallen; Study Chair: Franc H Hetzer, M D, Department of surgery, Cantonal hospital of St. Gallen

Publications and helpful links

General Publications

• 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. doi: 10.1024/1661-8157.96.31.1171. German.
• 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. doi: 10.1007/s004649900851.
• Muller 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: 10.1007/DCR.0b013e3182051d96.

Helpful Links

• Website of our clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): June 29, 2011
• Last Update Submitted That Met QC Criteria: June 3, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: recurrence; pilonidal sinus; Limberg flap
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: EKSG 07/050/2B