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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.
Patients, that come to our clinic with problems caused by a pilonidal sinus are informed about the different treatment options of the illness.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilonidal Sinus T. With Limberg F. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limberg-flap | Procedure | Complete excision of the pilonidal sinus and covering of the defect by a Limberg-flap from one buttock |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Marti, M D | Department of surgery, Cantonal hospital of St. Gallen | Principal Investigator |
| Franc H Hetzer, M D | Department of surgery, Cantonal hospital of St. Gallen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of sugery, Cantonal hospital of St. Gallen | Rorschach | Canton of St. Gallen | 9400 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17726856 | Background | 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. | |
| 9788857 | Background | 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. |
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1 patient excluded because of mental handicap
All patients meeting the inclusion criteria during the study recruiting period, who gave their consent included.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Number | participants | 1 year |
|
1 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication | Infections and infestations | Systematic Assessment | All complications were assessed. Apart from a bleeding which stopped with compression, all were infections or wound dehiscences. |
Study was conducted as planned. A long time was needed to get the follow-up information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lukas Marti; principal investigator | Department of surgery, Cantonal hospital of St. Gallen | 0041794120153 | lukas.marti@kssg.ch |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| 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 |
| Department of surgery, Cantonal hospital of St. Gallen |
| Sankt Gallen |
| Canton of St. Gallen |
| 9007 |
| Switzerland |
| 21383571 | Result | 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | participants | 1 year |
|
|
|
| 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. | Posted | Number | Reoperations | 1year |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 1 year |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 1 year |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 1 year |
|
|
|
| 0 |
| 70 |
| 18 |
| 70 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |