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Surgical Approach for Pilonidal Disease

Unroofing Curettage Versus Modified Limberg Flap in Pilonidal Disease: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04334681
Enrollment
278
Registered
2020-04-06
Start date
2020-04-02
Completion date
2020-10-01
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Disease

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

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.

Interventions

PROCEDUREUn-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.

PROCEDUREModified Limberg Flap Group

In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.

Sponsors

Konya Meram State Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mobilization Time,Days15 daysTime to return to the daily activities of the patients were measured.
Number of Participants With Recurring DiseaseNumber of Participants with Recurring Disease, up to five yearsIt 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 Timeoperation time, up to 100 minutesMean operation time was determined in minutes in both groups.
Hospitalization TimeHospitalization time, up to 15 daysIn both groups, hospitalization will be determined as a day.

Countries

Turkey (Türkiye)

Participant flow

Pre-assignment details

When we planned to study, we estimated 200 patients. However, we reached 278 patient data and analyzed them.

Participants by arm

ArmCount
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.
135
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.
143
Total278

Baseline characteristics

CharacteristicLF GroupTotalUC Group
Age, Continuous26.42 years
STANDARD_DEVIATION 7.9
25.90 years
STANDARD_DEVIATION 8.4
25.35 years
STANDARD_DEVIATION 8.9
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Turkey
143 participants278 participants135 participants
Sex: Female, Male
Female
16 Participants36 Participants20 Participants
Sex: Female, Male
Male
127 Participants242 Participants115 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1350 / 143
other
Total, other adverse events
2 / 13512 / 143
serious
Total, serious adverse events
1 / 1352 / 143

Outcome results

Primary

Hospitalization Time

In both groups, hospitalization will be determined as a day.

Time frame: Hospitalization time, up to 15 days

ArmMeasureValue (MEAN)Dispersion
UC GroupHospitalization Time0.24 daysStandard Deviation 0.45
MLF GroupHospitalization Time1.07 daysStandard Deviation 0.26
Primary

Mobilization Time,Days

Time to return to the daily activities of the patients were measured.

Time frame: 15 days

ArmMeasureValue (MEDIAN)Dispersion
UC GroupMobilization Time,Days3.21 daysStandard Deviation 3.7
MLF GroupMobilization Time,Days12.3 daysStandard Deviation 7.3
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; * New sinus orifice formation, * Or discharge from the sinus orifice

Time frame: Number of Participants with Recurring Disease, up to five years

ArmMeasureValue (NUMBER)
UC GroupNumber of Participants With Recurring Disease6 participants
MLF GroupNumber of Participants With Recurring Disease2 participants
Primary

Operation Time

Mean operation time was determined in minutes in both groups.

Time frame: operation time, up to 100 minutes

ArmMeasureValue (MEAN)Dispersion
UC GroupOperation Time11.44 minuteStandard Deviation 3.56
MLF GroupOperation Time52.47 minuteStandard Deviation 7.92

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026