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Набор скоро начнётся NCT07420452

Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial

Без фазы С лечением Pilonidal Sinus Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SiLac (Laser Ablation), Phenol Application.
Кому может быть актуально
Состояния в реестре: Pilonidal Sinus Disease. Базовые параметры: 18 лет — 64 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of Silac and Phenol Treatments in Primary Pilonidal Sinus Disease: A Prospective Randomized Controlled Trial With 6-Month Follow-up

Обзор

Pilonidal sinus disease is a common condition affecting young adults and is associated with pain, infection, and reduced quality of life. Various minimally invasive treatment options have been developed to reduce recurrence and improve recovery time. Among these methods, Silac (laser ablation) and phenol application are frequently used techniques. The aim of this prospective randomized controlled trial is to compare the effectiveness and safety of Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients will be randomly assigned to receive either Silac or phenol treatment. The primary outcome of the study is recurrence rate. Secondary outcomes include postoperative pain, healing time, time to return to work, patient satisfaction, and treatment cost. Patient recruitment is planned over a 6-month period, and each participant will be followed for 6 months after treatment. The total study duration will be 12 months. The results of this study are expected to provide evidence to guide the selection of minimally invasive treatment options for primary pilonidal sinus disease.

Подробное описание

Pilonidal sinus disease (PSD) is a chronic inflammatory condition commonly affecting young adults and is associated with significant morbidity, including pain, recurrent infections, and impaired quality of life. Minimally invasive treatment approaches have gained popularity in recent years in order to reduce postoperative pain, shorten recovery time, and lower recurrence rates compared to conventional excisional surgery.

Silac (laser ablation of the sinus tract) and phenol application are two minimally invasive techniques currently used in the management of primary pilonidal sinus disease. Although both methods are widely practiced, high-quality comparative evidence regarding their relative effectiveness remains limited.

This prospective randomized controlled trial aims to compare Silac and phenol treatments in patients with primary pilonidal sinus disease. Eligible patients aged 18-64 years with primary disease, a maximum of three pits, and no more than two prior abscess episodes will be included. Patients with recurrent or secondary disease and significant comorbidities will be excluded.

Participants will be randomly allocated in a 1:1 ratio to receive either Silac or phenol treatment. The primary outcome measure is recurrence rate during follow-up. Secondary outcomes include postoperative pain assessed by Visual Analog Scale (VAS), wound healing time, time to return to work, patient satisfaction, and cost analysis.

Patient recruitment will be conducted over a 6-month period. Each participant will be followed for 6 months after treatment, resulting in a total study duration of 12 months. Statistical analysis will be performed to compare outcomes between groups, with significance set at p \< 0.05.

Вмешательства

  • Процедура SiLac (Laser Ablation)
    Laser ablation of the pilonidal sinus tract performed according to the study protocol.
  • Процедура Phenol Application
    Chemical ablation with phenol performed according to the study protocol.

Первичные конечные точки

  • Recurrence Rate [Срок оценки: 6 month]
Вторичные конечные точки (7)
  • Postoperative Pain (VAS Score) [Срок оценки: Postoperative day 1 and week 1]
  • Postoperative Analgesic Consumption [Срок оценки: Within the first postoperative week]
  • Wound Healing Time [Срок оценки: Up to 6 months]
  • Wound-Related Complications [Срок оценки: Within 6 months after treatment]
  • Time to Return to Work [Срок оценки: Within 6 months after treatment]
  • Patient Satisfaction [Срок оценки: At 6 months after treatment]
  • Treatment Cost [Срок оценки: During the 6-month follow-up period]

Критерии участия

Критерии включения

  • Age between 18 and 64 years
  • Diagnosis of primary pilonidal sinus disease
  • Maximum of three sinus openings (pits)
  • History of no more than two previous abscess episodes
  • Ability to provide written informed consent

Критерии исключения

  • Recurrent or previously operated pilonidal sinus disease
  • More than three sinus openings
  • More than two previous abscess episodes
  • Acute abscess requiring emergency drainage at presentation
  • Presence of significant uncontrolled comorbidities
  • Pregnancy
  • Inability to comply with follow-up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Izmir City Hospital — Izmir

Идентификаторы

NCT: NCT07420452 · PNS-RCT-2026-SILPHEN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗