Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery

Обзор

Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.

Подробное описание

As above.

Вмешательства

• Процедура Robotic surgery using the Sentire Surgical System
  Robotic surgery using the Sentire Surgical System

Первичные конечные точки

• Conversion rate [Срок оценки: Up to 1 month]
• Perioperative complications [Срок оценки: Up to 1 month]

Вторичные конечные точки (10)

• Operative time [Срок оценки: Up to 1 month]
• Operative blood loss [Срок оценки: Up to 1 month]
• Pain scores on a visual analog scale [Срок оценки: Up to 1 month]
• Analgesic requirement [Срок оценки: Up to 1 month]
• Length of hospital stay [Срок оценки: Up to 1 month]
• Resection margin positivity for malignancy [Срок оценки: Up to 1 month]
• Number of lymph nodes harvested [Срок оценки: Up to 1 month]
• Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score) [Срок оценки: Up to 12 months]
• Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire) [Срок оценки: Up to 12 months]
• Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS) [Срок оценки: Up to 12 months]

Критерии участия

General Inclusion Criteria for All Procedures:

• Body mass index <35 kg/m2
• Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
• Willingness to participate as demonstrated by giving informed consent

General Exclusion Criteria for All Procedures:

• Contraindication to general anesthesia
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
• Untreated active infection
• Noncorrectable coagulopathy
• Presence of another malignancy or distant metastasis
• Emergency surgery
• Vulnerable population (e.g., mentally disabled, pregnancy)

Robotic Colorectal Resection

Критерии включения

\- Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery

Критерии исключения

• T4 tumor
• Recurrent tumor
• Extensive previous abdominal surgery precluding minimally invasive surgery

Robotic Transanal Total Mesorectal Excision

Критерии включения

\- Mid/low rectal adenocarcinoma located <12 cm from the anal verge

Критерии исключения

• T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
• Tumor requiring multivisceral resection
• Tumor requiring abdominoperineal resection; recurrent rectal tumor
• T1 tumor that can be treated by local excision
• Extensive previous abdominal surgery

Robotic Rectopexy

Критерии включения

• Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele

Критерии исключения

\- Extensive previous abdominal surgery precluding minimally invasive surgery

Radical Prostatectomy

Критерии включения

\- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate

Критерии исключения

\- Previous history of prostate surgery (e.g., transurethral resection of prostate)

Total or Partial Nephrectomy

Критерии включения

\- Clinically diagnosed with nonmetastatic kidney cancer

Критерии исключения

• Previous ipsilateral kidney surgery
• Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)

Radical Cystectomy

Критерии включения

\- Clinically diagnosed with nonmetastatic bladder cancer

Robotic Esophageal Hiatal Surgery and Fundoplication

Критерии включения

\- Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication

Критерии исключения

\- Previous history of laparotomy precluding minimally invasive surgery

Robotic Gastrectomy

Критерии включения

\- Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy

Критерии исключения

\- Previous history of laparotomy precluding minimally invasive surgery

Robotic Esophagectomy

Критерии включения

\- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy

Критерии исключения

\- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy

Robotic Cholecystectomy

Критерии включения

\- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy

Критерии исключения

• Acute cholecystitis
• Previous history of abdominal surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Prince of Wales Hospital, The Chinese University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06926374 · CREC 2025.109-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗