RATME Vs LATME in Middle and Low Rectal Cancer

Официальное название

A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.

Обзор

This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.

Подробное описание

Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.

This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.

Вмешательства

• Процедура Robotic-assisted total mesorectal excision
  TME will be performed with the assistance of robot in rectal cancer
• Процедура laparoscopic-assisted total mesorectal excision
  TME will be performed with the assistance of laparoscopy in rectal cancer

Первичные конечные точки

• intersphincteric resection (ISR) [Срок оценки: during the operation]

Вторичные конечные точки (12)

• coloanal anastomosis (CAA) [Срок оценки: during the operation]
• conversion to open [Срок оценки: during the operation]
• conversion to transanal TME (TaTME) [Срок оценки: during the operation]
• 30-day postoperative morbidity [Срок оценки: within 30 days after operation]
• 30-day postoperative mortality [Срок оценки: within 30 days after operation]
• 3-year disease-free survival (DFS) [Срок оценки: 3 years after operation]
• 3-year local recurrence rate (LR) [Срок оценки: 3 years after operation]
• 3-year overall survival (OS) [Срок оценки: 3 years after operation]
• distance to distal resection margin (DRM) [Срок оценки: within 30 days after operation]
• distance to circumferential resection margin (CRM) [Срок оценки: within 30 days after operation]
• 3-year urinary function [Срок оценки: 3 years after operation]
• The proportion of patients receiving abdominoperineal resection [Срок оценки: during the operation]

Критерии участия

Критерии включения

• male patients diagnosed with rectal cancer by pathological biopsy;
• abdominal contrast-enhanced and chest computed tomography (CT) or positron emission tomography-computed tomography (PET-CT) revealed no distal metastasis;
• Preoperative rectal magnetic resistance (MR) evaluation showed that the tumor was located at or below the peritoneal reflux plane, and at least 1cm above the anal sphincter groove, and did not invade the external anal sphincter;
• Tumors located above the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-3, cN0-1, M0, and MRF (-); The tumors located below the hiatus of levator ani muscle were evaluated by magnetic resonance imaging as cT1-2, cN0-1, M0, and MRF (-). After neoadjuvant treatment, the tumor above the hiatus of levator ani muscle is ycT3NxM0 or below; The tumor below the hiatus of levator ani muscle is ycT2NxM0;
• The patient underwent laparoscopic assisted TME surgery or robotic assisted TME surgery.

Критерии исключения

• multiple primary cancers;
• history of open surgery;
• no preoperative MR evaluation and inadequate evaluation of tumor stage;
• Patients with rectal cancer who undergo endoscopic resection first and need subsequent transabdominal resection;
• Pregnant or patients with concomitant inflammatory bowel disease;
• Patients with preoperative complete bowel obstruction or requiring emergency surgery;
• Preoperative evaluation indicates that patient may require combined organ resection;
• Recently receiving treatment for other malignant tumors;
• Bordeaux type IV low rectal cancer;
• The preoperative pathological types are signet ring cell carcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma.

Exit Criteria

• Refuse surgical treatment after randomization;
• Open surgery was performed for treatment after randomization;
• Patients request to withdraw from the study at any time during the entire study process after randomization

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Hospital of Jilin University — Changchun

Публикации

• Guo Y, He L, Tong W, Chi Z, Ren S, Cui B, Wang Q. A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial. Trials. 2024 Oct 21;25(1):703. doi: 10.1186/s13063-024-08561-4. PMID 39434171

Идентификаторы

NCT: NCT06105203 · STARS-RC05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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