Limberg-flap: Prospective Data Collection
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Limberg-flap
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus focused on measuring pilonidal sinus, recurrence, Limberg flap
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.
Sites / Locations
- Department of sugery, Cantonal hospital of St. Gallen
- Department of surgery, Cantonal hospital of St. Gallen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilonidal Sinus T. With Limberg F.
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00672555
First Posted
May 1, 2008
Last Updated
June 3, 2011
Sponsor
Cantonal Hospital of St. Gallen
1. Study Identification
Unique Protocol Identification Number
NCT00672555
Brief Title
Limberg-flap: Prospective Data Collection
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cantonal Hospital of St. Gallen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
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.
Patients, who gave their informed consent for the operation and the study are included.
Preoperative data are recorded.
The patients are operated on and intraoperative data (e.g. how big was the flap) are recorded.
After 3 Weeks the patients are checked and complications, happiness and duration of the time off work are recorded.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
pilonidal sinus, recurrence, Limberg flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilonidal Sinus T. With Limberg F.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Limberg-flap
Other Intervention Name(s)
Romboid-flap
Intervention Description
Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock
Primary Outcome Measure Information:
Title
Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Minor Complications (Wound Complications)
Description
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.
Time Frame
1 year
Title
Reoperations Needed for Treatment of Complication
Description
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.
Time Frame
1year
Title
Patient Overall Satisfaction With Procedure
Description
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.
Time Frame
1 year
Title
Body Image Score
Description
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.
Time Frame
1 year
Title
Cosmetic Score
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Marti, M D
Organizational Affiliation
Department of surgery, Cantonal hospital of St. Gallen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franc H Hetzer, M D
Organizational Affiliation
Department of surgery, Cantonal hospital of St. Gallen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of sugery, Cantonal hospital of St. Gallen
City
Rorschach
State/Province
St. Gallen
ZIP/Postal Code
9400
Country
Switzerland
Facility Name
Department of surgery, Cantonal hospital of St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17726856
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. doi: 10.1024/1661-8157.96.31.1171. German.
Results Reference
background
PubMed Identifier
9788857
Citation
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.
Results Reference
background
PubMed Identifier
21383571
Citation
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.
Results Reference
result
Links:
URL
http://www.surgery.ch
Description
Website of our clinic
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Limberg-flap: Prospective Data Collection
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