Clinical trial NCT06926374: Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Official title: Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Rectal Prolapse
Prostate Cancer (Adenocarcinoma)
Bladder Cancer
Kidney Cancer
Hiatal Hernia With Gastroesophageal Reflux Disease
GIST - Gastrointestinal Stromal Tumor
Esophageal Cancer
Gallstones
Gastric Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: As above.

Eligibility criteria: 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

Inclusion Criteria:

- 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

Exclusion Criteria:

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

Robotic Transanal Total Mesorectal Excision

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Inclusion Criteria:

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

Exclusion Criteria:

- Extensive previous abdominal surgery precluding minimally invasive surgery

Radical Prostatectomy

Inclusion Criteria:

- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate

Exclusion Criteria:

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

Total or Partial Nephrectomy

Inclusion Criteria:

- Clinically diagnosed with nonmetastatic kidney cancer

Exclusion Criteria:

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

Radical Cystectomy

Inclusion Criteria:

- Clinically diagnosed with nonmetastatic bladder cancer

Robotic Esophageal Hiatal Surgery and Fundoplication

Inclusion Criteria:

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

Exclusion Criteria:

- Previous history of laparotomy precluding minimally invasive surgery

Robotic Gastrectomy

Inclusion Criteria:

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

Exclusion Criteria:

- Previous history of laparotomy precluding minimally invasive surgery

Robotic Esophagectomy

Inclusion Criteria:

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

Exclusion Criteria:

- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy

Robotic Cholecystectomy

Inclusion Criteria:

- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy

Exclusion Criteria:

* Acute cholecystitis
* Previous history of abdominal surgery

Primary outcomes:
measure: Conversion rate
timeFrame: Up to 1 month
measure: Perioperative complications
timeFrame: Up to 1 month
Secondary outcomes:
measure: Operative time
timeFrame: Up to 1 month
measure: Operative blood loss
timeFrame: Up to 1 month
measure: Pain scores on a visual analog scale
timeFrame: Up to 1 month
measure: Analgesic requirement
timeFrame: Up to 1 month
measure: Length of hospital stay
timeFrame: Up to 1 month
measure: Resection margin positivity for malignancy
timeFrame: Up to 1 month
measure: Number of lymph nodes harvested
timeFrame: Up to 1 month
measure: Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)
timeFrame: Up to 12 months
measure: Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)
timeFrame: Up to 12 months
measure: Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: