Trial Outcomes & Findings for Surgical Approach for Pilonidal Disease (NCT NCT04334681)

NCT ID: NCT04334681

Last Updated: 2022-10-27

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 278 participants
• Primary outcome timeframe: 15 days
• Results posted on: 2022-10-27

Participant Flow

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

Participant milestones

Measure	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.	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.
Overall Study STARTED	135	143
Overall Study COMPLETED	135	143
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	UC Group n=135 Participants 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.	LF Group n=143 Participants 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 n=278 Participants Total of all reporting groups
Age, Continuous	25.35 years STANDARD_DEVIATION 8.9 • n=135 Participants	26.42 years STANDARD_DEVIATION 7.9 • n=143 Participants	25.90 years STANDARD_DEVIATION 8.40 • n=278 Participants
Sex: Female, Male Female	20 Participants n=135 Participants	16 Participants n=143 Participants	36 Participants n=278 Participants
Sex: Female, Male Male	115 Participants n=135 Participants	127 Participants n=143 Participants	242 Participants n=278 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	135 participants n=135 Participants	143 participants n=143 Participants	278 participants n=278 Participants

PRIMARY outcome

Timeframe: 15 days

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

Outcome measures

Measure	UC Group n=135 Participants 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.	MLF Group n=143 Participants 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.
Mobilization Time,Days	3.21 days Standard Deviation 3.7	12.3 days Standard Deviation 7.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	UC Group n=143 Participants 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.	MLF Group n=135 Participants 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.
Number of Participants With Recurring Disease	6 participants	2 participants

PRIMARY outcome

Timeframe: operation time, up to 100 minutes

Mean operation time was determined in minutes in both groups.

Outcome measures

Measure	UC Group n=135 Participants 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.	MLF Group n=143 Participants 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.
Operation Time	11.44 minute Standard Deviation 3.56	52.47 minute Standard Deviation 7.92

PRIMARY outcome

Timeframe: Hospitalization time, up to 15 days

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

Outcome measures

Measure	UC Group n=135 Participants 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.	MLF Group n=143 Participants 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.
Hospitalization Time	0.24 days Standard Deviation 0.45	1.07 days Standard Deviation 0.26

Adverse Events

UC Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

LF Group

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	UC Group n=135 participants at risk 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.	LF Group n=143 participants at risk 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.
Injury, poisoning and procedural complications Hemorrhage	0.74% 1/135 • Number of events 1 • 6 months	0.70% 1/143 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Hematoma	0.00% 0/135 • 6 months	0.70% 1/143 • Number of events 1 • 6 months

Other adverse events

Measure	UC Group n=135 participants at risk 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.	LF Group n=143 participants at risk 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.
Skin and subcutaneous tissue disorders Wound İnfection	1.5% 2/135 • Number of events 2 • 6 months	5.6% 8/143 • Number of events 8 • 6 months
Skin and subcutaneous tissue disorders Wound dehiscence	0.00% 0/135 • 6 months	2.8% 4/143 • Number of events 4 • 6 months

Additional Information

Dr. Alpaslan Şahin

Principal investigator

Phone: 0332310500

Email: drasahin@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place