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Идёт набор NCT07520734

Clinical Outcomes After Laser Hemorrhoidoplasty

Наблюдательное Hemorrhoidal Disease Internal Hemorrhoids

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: Laser Hemorrhoidoplasty.
Кому может быть актуально
Состояния в реестре: Hemorrhoidal Disease, Internal Hemorrhoids. Базовые параметры: от 18 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Clinical Outcomes, Pain Scores, and Patient Satisfaction in Patients Undergoing Laser Hemorrhoidoplasty: A Prospective Observational Study

Обзор

This single-center prospective observational study aims to evaluate clinical outcomes, postoperative pain scores, complications, and patient satisfaction in adults undergoing laser hemorrhoidoplasty for symptomatic internal hemorrhoidal disease. Additional objectives are to assess the relationship between hemorrhoid stage, dominant presenting symptoms, operative technical details, and postoperative outcomes. No study-specific intervention beyond routine clinical care and follow-up will be performed.

Подробное описание

Hemorrhoidal disease is a common benign anorectal condition that can significantly impair quality of life. Conventional excisional techniques may be associated with postoperative pain, bleeding, prolonged recovery, and lower patient satisfaction. Laser hemorrhoidoplasty is a minimally invasive technique based on coagulation and shrinkage of hemorrhoidal tissue without excision. This prospective observational study will be conducted at the General Surgery Clinic of Sanliurfa Education and Research Hospital. Adult patients with symptomatic internal hemorrhoidal disease who are scheduled to undergo laser hemorrhoidoplasty will be enrolled. Preoperative symptoms, hemorrhoid stage, and physical examination findings will be recorded. Intraoperative data will include laser wavelength, total delivered energy, number of hemorrhoidal packages treated, and any additional surgical procedures. Postoperative pain will be assessed at predefined time points using the Visual Analog Scale. Analgesic requirement and duration, length of hospital stay, time to return to daily activities, early complications within 30 days, late complications, symptom status, and recurrence at 6 months will be documented. The study is designed to clarify the clinical role of laser hemorrhoidoplasty and help define appropriate patient selection criteria.

Вмешательства

  • Процедура Laser Hemorrhoidoplasty
    Laser-based minimally invasive treatment of internal hemorrhoidal disease performed as part of routine clinical care.

Первичные конечные точки

  • Postoperative pain score [Срок оценки: At 6 hours, 24 hours, and 1 week after surgery]
Вторичные конечные точки (5)
  • Duration of postoperative analgesic use [Срок оценки: From the day of surgery through 30 days after surgery]
  • Length of hospital stay [Срок оценки: From the day of surgery to hospital discharge, up to 7 days]
  • Incidence of predefined early postoperative complications [Срок оценки: Within 30 days after surgery]
  • Time to return to daily activities [Срок оценки: Up to 30 days after surgery]
  • Patient satisfaction [Срок оценки: Up to 3 months after surgery]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Symptomatic internal hemorrhoidal disease
  • Scheduled to undergo laser hemorrhoidoplasty
  • Willingness to participate and provision of informed consent

Критерии исключения

  • Grade IV hemorrhoidal disease
  • Acute thrombosed hemorrhoids
  • Additional anorectal pathology such as anal fissure, fistula, or perianal abscess
  • History of inflammatory bowel disease or colorectal malignancy
  • Previous major anal surgery'

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sanliurfa Education and Research Hospital — Sanliurfa

Идентификаторы

NCT: NCT07520734 · SEAH-LHP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗