Идёт набор NCT06841484

Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy

Без фазы С лечением Gastric Cancer

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: Arm I (Assistant-Controlled Laparoscopic Instrumentation), Arm II (Assistant-Controlled Laparoscopic Instrumentation).
Кому может быть актуально: Состояния в реестре: Gastric Cancer. Базовые параметры: от 20 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: South Korea
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

Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study

Обзор

This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.

Вмешательства

Процедура Arm I (Assistant-Controlled Laparoscopic Instrumentation)
In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson \& Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining roboti
Процедура Arm II (Assistant-Controlled Laparoscopic Instrumentation)
In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure. Both groups follow the same po

Первичные конечные точки

Average operative time (in minutes). [Срок оценки: At the end of the surgery]

Вторичные конечные точки (5)

Total cost of consumable surgical materials. [Срок оценки: At the end of the surgery (up to 12 hours)]
Quality of Recovery (QoR-15) scores at 72 hours postoperatively. [Срок оценки: 72 hours postoperatively]
Time to first flatus and bowel movement. [Срок оценки: Up to 1 month after surgery]
Postoperative laboratory markers (e.g., CRP, WBC). [Срок оценки: Up to 5 days after surgery]
Incidence of postoperative complications. [Срок оценки: Within 30 days postoperatively]

Критерии участия

Критерии включения

Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
Patients who have undergone a complete (R0) resection.
Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
Patients undergoing robotic radical distal gastrectomy.