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In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients will be divided into two groups as Un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Operation time, hospital stay time, return to work time, recovery time, Time to walk without pain, days, Time to sit on the toilet without pain, days, Postoperative VAS and recurrence will be compared between both groups
In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients who are well followed up will be included in the study. Demographic features will be recorded. Patients will be divided into two groups, the un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Surgery time, hospital stay, return to work time, recovery time, painless walking time, days, painless sitting time in the toilet, days, postoperative VAS, and recurrence will be compared between both groups. In addition, mobilization time, days, recovery time, days, exclusion time, days, wound infection, wound distribution will be compared between groups. The results will be analyzed with the SPSS statistics program. Factors affecting recurrence wound infection, recovery time, hospital stay, operation time, early mobilization will be evaluated by univariate and multivariate logistic regression analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC Group | Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group. |
| |
| LF Group | Patients who have been operated with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Un-roofing curettage method | Procedure | In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Mobilization Time,Days | Time to return to the daily activities of the patients were measured. | 15 days |
| Number of Participants With Recurring Disease | It has been reported in the literature that a five or ten year follow-up period is required for the effective evaluation of recurrence. In both groups, the number of recurrent patients during the follow-up period will be determined. Observation of the following findings on physical examination made a diagnosis of recurrence;
| Number of Participants with Recurring Disease, up to five years |
| Operation Time | Mean operation time was determined in minutes in both groups. | operation time, up to 100 minutes |
| Hospitalization Time | In both groups, hospitalization will be determined as a day. | Hospitalization time, up to 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Limberg flap after rhomboid excision and un-roofing curettage between January 2013 and January 2017 in our hospital constitute the study population.
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| Name | Affiliation | Role |
|---|---|---|
| Kemal Arslan, MD | Konya Research and Training Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya Training and Research Hospital | Konya | 42090 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18937009 | Background | Mahdy T. Surgical treatment of the pilonidal disease: primary closure or flap reconstruction after excision. Dis Colon Rectum. 2008 Dec;51(12):1816-22. doi: 10.1007/s10350-008-9436-8. Epub 2008 Oct 21. | |
| 19820992 | Background | Kepenekci I, Demirkan A, Celasin H, Gecim IE. Unroofing and curettage for the treatment of acute and chronic pilonidal disease. World J Surg. 2010 Jan;34(1):153-7. doi: 10.1007/s00268-009-0245-6. |
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When we planned to study, we estimated 200 patients. However, we reached 278 patient data and analyzed them.
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| ID | Title | Description |
|---|---|---|
| FG000 | UC Group | Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. |
| FG001 | LF Group | Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UC Group | Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mobilization Time,Days | Time to return to the daily activities of the patients were measured. | Posted | Median | Standard Deviation | days | 15 days |
|
6 months
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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 | UC Group | Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment | Post-operative bleeding from the wound site |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound İnfection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | wound infection development in the postoperative period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alpaslan Şahin | Principal investigator | 0332310500 | 50510 | drasahin@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2020 | Oct 21, 2022 | Prot_SAP_001.pdf |
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| Modified Limberg Flap Group | Procedure | In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method. |
|
| 19333052 | Background | Karakayali F, Karagulle E, Karabulut Z, Oksuz E, Moray G, Haberal M. Unroofing and marsupialization vs. rhomboid excision and Limberg flap in pilonidal disease: a prospective, randomized, clinical trial. Dis Colon Rectum. 2009 Mar;52(3):496-502. doi: 10.1007/DCR.0b013e31819a3ec0. |
| 34840296 | Result | Sahin A, Simsek G, Arslan K. Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study. Dis Colon Rectum. 2022 Oct 1;65(10):1241-1250. doi: 10.1097/DCR.0000000000002227. Epub 2022 May 24. |
| LF Group |
Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Recurring Disease | It has been reported in the literature that a five or ten year follow-up period is required for the effective evaluation of recurrence. In both groups, the number of recurrent patients during the follow-up period will be determined. Observation of the following findings on physical examination made a diagnosis of recurrence;
| Posted | Number | participants | Number of Participants with Recurring Disease, up to five years |
|
|
|
| Primary | Operation Time | Mean operation time was determined in minutes in both groups. | Posted | Mean | Standard Deviation | minute | operation time, up to 100 minutes |
|
|
|
| Primary | Hospitalization Time | In both groups, hospitalization will be determined as a day. | Posted | Mean | Standard Deviation | days | Hospitalization time, up to 15 days |
|
|
|
| 0 |
| 135 |
| 1 |
| 135 |
| 2 |
| 135 |
| EG001 | LF Group | Patients who have been operated with the Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the Limberg flap method. | 0 | 143 | 2 | 143 | 12 | 143 |
|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | Postoperative hematoma (clotted blood accumulation) from the wound site |
|
|
| Wound dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment | wound dehiscence in the postoperative period |
|
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