Clinical trial NCT00672555: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: pilonidal sinus
recurrence
Limberg flap
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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 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.

Primary outcomes:
measure: Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure
timeFrame: 1 year
Secondary outcomes:
measure: Minor Complications (Wound Complications)
timeFrame: 1 year
measure: Reoperations Needed for Treatment of Complication
timeFrame: 1year
measure: Patient Overall Satisfaction With Procedure
timeFrame: 1 year
measure: Body Image Score
timeFrame: 1 year
measure: Cosmetic Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Rorschach
country: Switzerland
facility: Department of sugery, Cantonal hospital of St. Gallen
state: St. Gallen
city: St. Gallen
country: Switzerland
facility: Department of surgery, Cantonal hospital of St. Gallen
Study officials:
affiliation: Department of surgery, Cantonal hospital of St. Gallen
name: Lukas Marti, M D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of surgery, Cantonal hospital of St. Gallen
name: Franc H Hetzer, M D
role: STUDY_CHAIR
References:
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.
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.
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.