Limberg-flap: Prospective Data Collection

This study has been completed.
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00672555
First received: May 1, 2008
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Pilonidal Sinus
Procedure: Limberg-flap

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Minor Complications (Wound Complications) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Reoperations Needed for Treatment of Complication [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

    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.


  • Patient Overall Satisfaction With Procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Body Image Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Cosmetic Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Romboid-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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672555

Locations
Switzerland
Department of sugery, Cantonal hospital of St. Gallen
Rorschach, St. Gallen, Switzerland, 9400
Department of surgery, Cantonal hospital of St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Dr. med. D. Germann; (MD), Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00672555     History of Changes
Other Study ID Numbers: EKSG 07/050/2B
Study First Received: May 1, 2008
Results First Received: April 28, 2010
Last Updated: June 3, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
pilonidal sinus
recurrence
Limberg flap

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014