Pilonidal Sinus
Conditions
Keywords
pilonidal sinus, recurrence, Limberg flap
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.
Interventions
PROCEDURELimberg-flap
Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Minor Complications (Wound Complications) | 1 year | 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 | 1year | 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 | 1 year | 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 | 1 year | 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 | 1 year | 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. |
Countries
Switzerland
Participant flow
Recruitment details
All patients meeting the inclusion criteria during the study recruiting period, who gave their consent included.
Pre-assignment details
1 patient excluded because of mental handicap
Participants by arm
| Arm | Count |
|---|---|
| Pilonidal Sinus Treated With Limberg Flap 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. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not want to answer questionnaire | 2 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Pilonidal Sinus Treated With Limberg Flap |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age Continuous | 26.1 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment Switzerland | 70 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
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.
Time frame: 1 year
Population: Per protocol:~All patients treated in the study period, who gave their informed consent and meet the inclusion criteria, as well did not have any reason for exclusion were enrolled prospectively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure | 1 participants |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Body Image Score | 17.9 Units on a scale | Standard Deviation 2.6 |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Cosmetic Score | 16.4 Units on a scale | Standard Deviation 4.3 |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Minor Complications (Wound Complications) | 18 participants |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Patient Overall Satisfaction With Procedure | 7.6 Units on a scale | Standard Deviation 2.3 |
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.
Time frame: 1year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pilonidal Sinus Treated With Limberg Flap | Reoperations Needed for Treatment of Complication | 6 Reoperations |