Trial Outcomes & Findings for Limberg-flap: Prospective Data Collection (NCT NCT00672555)

NCT ID: NCT00672555

Last Updated: 2011-06-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2011-06-29

Participant Flow

All patients meeting the inclusion criteria during the study recruiting period, who gave their consent included.

1 patient excluded because of mental handicap

Participant milestones

Measure	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.
Overall Study STARTED	70
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	4
Overall Study Did not want to answer questionnaire	2

Baseline Characteristics

Limberg-flap: Prospective Data Collection

Baseline characteristics by cohort

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	26.1 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Region of Enrollment Switzerland	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: 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

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Recurrence of a Pilonidal Sinus After Operation Using a Limberg-flap Procedure	1 participants

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Minor Complications (Wound Complications)	18 participants

SECONDARY outcome

Timeframe: 1year

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Reoperations Needed for Treatment of Complication	6 Reoperations

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Patient Overall Satisfaction With Procedure	7.6 Units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Body Image Score	17.9 Units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 Participants 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.
Cosmetic Score	16.4 Units on a scale Standard Deviation 4.3

Adverse Events

Pilonidal Sinus Treated With Limberg Flap

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pilonidal Sinus Treated With Limberg Flap n=70 participants at risk 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.
Infections and infestations Complication	25.7% 18/70 • Number of events 18 • 1 years

Additional Information

Lukas Marti; principal investigator

Department of surgery, Cantonal hospital of St. Gallen

Phone: 0041794120153

Email: lukas.marti@kssg.ch

Results disclosure agreements

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