Идёт набор NCT07404774

Hemorrhoid Suture Mucopexy Combined With Laser Hemorrhoidoplasty

— Наблюдательное Haemorrhoid Haemorrhoidal Bleeding Anorectal Surgeries Anorectal Diseases

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 Haemorrhoidoplasty and Suture Mucopexy.
Кому может быть актуально: Состояния в реестре: Haemorrhoid, Haemorrhoidal Bleeding, Anorectal Surgeries, Anorectal Diseases. 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: Греция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Evaluation of Hemorrhoid Suture Mucopexy (SM) Combined With Laser Hemorrhoidoplasty (LHP) for Symptomatic Hemorrhoidal Disease: A Cohort Study

Обзор

This prospective cohort study evaluates whether combining "suture mucopexy" (a simple stitch-based lift of prolapsed tissue) with Laser Hemorrhoidoplasty (LHP) can effectively relieve pain, bleeding and prolapse in adults with moderate-to-severe hemorrhoids (Grades II-IV). Participants will undergo the combined, non-Doppler-guided procedure and be followed for one year. The primary question is how long patients need post-operative pain medication and if they first experience complete symptom relief; secondary questions examine quality-of-life, safety (bleeding, urinary retention, stenosis) and the rate of hemorrhoid recurrence/re-operation.

Подробное описание

Laser Hemorrhoidoplasty (LHP) offers a minimally invasive option for symptomatic hemorrhoids, yet in advanced disease (Goligher III/IV) recurrence rates of 20-35 % have been reported because residual mucosal prolapse persists. Adding a suture-based mucopexy (SM) eliminates the prolapse and ligates feeding vessels without the need for Doppler guidance, thereby potentially reducing recurrence while preserving the low-pain advantage of LHP. Preliminary experience with 50 patients at this centre demonstrated feasibility, low early complication rates, and promising symptom control, justifying a formal prospective evaluation.

The present study is a single-center, prospective observational cohort enrolling consecutive eligible adults over a 24-month accrual period. All participants receive the same combined LHP + SM technique; no comparator arm is planned. Follow-up visits occur at postoperative week 6, month 6 and month 12.

Вмешательства

Процедура Laser Haemorrhoidoplasty and Suture Mucopexy
The procedure combines laser ablation (LHP) with suture mucopexy (SM) performed without Doppler guidance. Suture Mucopexy (SM): Using a slotted proctoscope, continuous suture mucopexy (plication) is performed at standardized anatomical positions (typically 4, 7, 11 o'clock) to lift the prolapse and ligate feeding vessels. Sutures are placed approximately 2-4 cm proximal to the dentate line. Laser Hemorrhoidoplasty (LHP): A 1470nm diode laser fiber is inserted into the hemorrhoidal cushion. Ene

Первичные конечные точки

Duration of analgesia [Срок оценки: perioperatively]
Primary Symptom Relief [Срок оценки: perioperatively]

Вторичные конечные точки (4)

Nyström Hemorrhoid Severity Score (HSS) [Срок оценки: 12 months]
Morbidity [Срок оценки: 3 months]
Complications [Срок оценки: 12 months]
Reoperation Rate [Срок оценки: 12 months]

Критерии участия

Критерии включения

Adults (>18 years).
Symptomatic Hemorrhoidal Disease (Goligher Grades II, III, IV).
Patients with or without recurrent disease after prior procedures (e.g., RBL, infrared coagulation, Milligan-Morgan, etc).