Идёт набор NCT06578065

Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

Без фазы С лечением Colorectal Anastomosis

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: Echelon Circular™ Powered Stapler, 2-row circular staplers manual.
Кому может быть актуально: Состояния в реестре: Colorectal Anastomosis. 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: Испания
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

Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.

Обзор

Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms: * ECPS group: Echelon Circular™ Powered Stapler (n=270) * MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.

Подробное описание

Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together with an increase in morbidity and mortality.

The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.

This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.

540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).

Anastomosis could be performed open, laparoscopically or with robotic assistance.

After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.

Вмешательства

Устройство Echelon Circular™ Powered Stapler
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
Устройство 2-row circular staplers manual
2-row circular staplers manual will be used in colorectal anastomosis.

Первичные конечные точки

Anastomotic leakage rates differences between both groups at 30 postoperative days [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (3)

Postoperative endoluminal bleeding rate differences between both groups. [Срок оценки: Through study completion, an average of 1 year]
Morbidity differences between groups according to the Clavien-Dindo classification. [Срок оценки: Through study completion, an average of 1 year]
Re-intervention rate differences between both groups [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

Patient or its legal representative informed consent.
Age ≥ 18 years.
Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).