Trials · 2018
Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Minneci Peter C, Halleran Devin R, Lawrence Amy E, Fischer Beth A, Cooper Jennifer N, Deans Katherine J
Аннотация
BACKGROUND: Laser hair depilation is a promising therapy in the management of pilonidal disease. However, the large controlled trials needed to demonstrate the effectiveness of this practice have not been performed.
METHODS: We designed a single-center randomized controlled trial that will enroll 272 patients with pilonidal disease. Patients will be randomized to receive laser hair depilation of the sacrococcygeal region or the best recommended standard of care. The primary outcome is the rate of recurrent pilonidal disease at 1 year, defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic treatment, additional surgical incision and drainage, or excision within 1 year of enrollment. Secondary outcomes include each of the following at 1 year: disability days of the patient, disability days of the caregiver, health-related quality of life, healthcare satisfaction, disease-related attitudes and perceived stigma, pilonidal disease-related complications, pilonidal disease-related procedures, surgical excision, postoperative complications, and compliance with recommended treatment.
DISCUSSION: This study will determine the effectiveness of laser hair depilation to reduce pilonidal disease recurrence in adolescents and young adults as compared to the best recommended standard of care.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03276065 . Registered on 8 September 2017.
METHODS: We designed a single-center randomized controlled trial that will enroll 272 patients with pilonidal disease. Patients will be randomized to receive laser hair depilation of the sacrococcygeal region or the best recommended standard of care. The primary outcome is the rate of recurrent pilonidal disease at 1 year, defined as development of a new pilonidal abscess, folliculitis, or draining sinus after treatment, which would require antibiotic treatment, additional surgical incision and drainage, or excision within 1 year of enrollment. Secondary outcomes include each of the following at 1 year: disability days of the patient, disability days of the caregiver, health-related quality of life, healthcare satisfaction, disease-related attitudes and perceived stigma, pilonidal disease-related complications, pilonidal disease-related procedures, surgical excision, postoperative complications, and compliance with recommended treatment.
DISCUSSION: This study will determine the effectiveness of laser hair depilation to reduce pilonidal disease recurrence in adolescents and young adults as compared to the best recommended standard of care.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03276065 . Registered on 8 September 2017.