Comparison of Un-roofing Curettage With Rhomboid Excision and Modified Limberg Flap
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| UC Group Patients operated on the un-roofing curettage method in the treatment of pilonidal disease will be analyzed in this group. |
Procedure: 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.
|
| 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. |
Procedure: Modified Limberg Flap Group
In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.
|
Outcome Measures
Primary Outcome Measures
- Mobilization Time,Days [15 days]
Time to return to the daily activities of the patients were measured.
- Number of Participants With Recurring Disease [Number of Participants with Recurring Disease, up to five years]
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; New sinus orifice formation, Or discharge from the sinus orifice
- Operation Time [operation time, up to 100 minutes]
Mean operation time was determined in minutes in both groups.
- Hospitalization Time [Hospitalization time, up to 15 days]
In both groups, hospitalization will be determined as a day.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients between the ages of 18 and 70
-
Patients with sufficient registration information
-
Telephone-accessible patients
Exclusion Criteria:
-
Patients under the age of 18
-
Patients over 70 years old
-
Common gluteal disease
-
Diabetes mellitus
-
Connective tissue disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Konya Training and Research Hospital | Konya | Turkey | 42090 |
Sponsors and Collaborators
- Konya Meram State Hospital
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- pilonidal surgery group
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | When we planned to study, we estimated 200 patients. However, we reached 278 patient data and analyzed them. |
| Arm/Group Title | UC Group | LF Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 135 | 143 |
| COMPLETED | 135 | 143 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | UC Group | LF Group | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 135 | 143 | 278 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
25.35
(8.9)
|
26.42
(7.9)
|
25.90
(8.40)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
14.8%
|
16
11.2%
|
36
12.9%
|
| Male |
115
85.2%
|
127
88.8%
|
242
87.1%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Turkey |
135
100%
|
143
100%
|
278
100%
|
Outcome Measures
| Title | Mobilization Time,Days |
|---|---|
| Description | Time to return to the daily activities of the patients were measured. |
| Time Frame | 15 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | UC Group | MLF Group |
|---|---|---|
| Arm/Group Description | Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. | Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method. |
| Measure Participants | 135 | 143 |
| Median (Standard Deviation) [days] |
3.21
(3.7)
|
12.3
(7.3)
|
| Title | Number of Participants With Recurring Disease |
|---|---|
| Description | 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; New sinus orifice formation, Or discharge from the sinus orifice |
| Time Frame | Number of Participants with Recurring Disease, up to five years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | MLF Group | UC Group |
|---|---|---|
| Arm/Group Description | Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method. | Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. |
| Measure Participants | 143 | 135 |
| Number [participants] |
6
4.4%
|
2
1.4%
|
| Title | Operation Time |
|---|---|
| Description | Mean operation time was determined in minutes in both groups. |
| Time Frame | operation time, up to 100 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | UC Group | MLF Group |
|---|---|---|
| Arm/Group Description | Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. | Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method. |
| Measure Participants | 135 | 143 |
| Mean (Standard Deviation) [minute] |
11.44
(3.56)
|
52.47
(7.92)
|
| Title | Hospitalization Time |
|---|---|
| Description | In both groups, hospitalization will be determined as a day. |
| Time Frame | Hospitalization time, up to 15 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | UC Group | MLF Group |
|---|---|---|
| Arm/Group Description | Patients operated on the un-roofing curettage method in treating the pilonidal disease will be analyzed in this group. Un-roofing curettage method: In this method, the pilonidal cyst roof is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis. | Patients who have been operated on with the modified Limberg flap method after rhomboid excision in the treatment of pilonidal disease will be analyzed in this group. Modified Limberg Flap Group: In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method. |
| Measure Participants | 135 | 143 |
| Mean (Standard Deviation) [days] |
0.24
(0.45)
|
1.07
(0.26)
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | UC Group | LF Group | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| UC Group | LF Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/135 (0%) | 0/143 (0%) | ||
Serious Adverse Events |
||||
| UC Group | LF Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/135 (0.7%) | 2/143 (1.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Hemorrhage | 1/135 (0.7%) | 1 | 1/143 (0.7%) | 1 |
| Hematoma | 0/135 (0%) | 0 | 1/143 (0.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| UC Group | LF Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/135 (1.5%) | 12/143 (8.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Wound İnfection | 2/135 (1.5%) | 2 | 8/143 (5.6%) | 8 |
| Wound dehiscence | 0/135 (0%) | 0 | 4/143 (2.8%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Alpaslan Şahin |
|---|---|
| Organization | prinipal investigator |
| Phone | 0332310500 ext 50510 |
| drasahin@gmail.com |
- pilonidal surgery group