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

Not Applicable

Recruiting

• 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

• Registration Number: NCT06926374
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2025-03-25
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Conversion rate	Up to 1 month	The definition of a conversion for this study is an emergent change in the treatment plan to conventional minimally invasive (laparoscopic/thoracoscopic) surgery (i.e., the use of more than one additional port), multiport robotic surgery, or to open surgery.
Perioperative complications	Up to 1 month	Perioperative complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification. Complications of Clavien-Dindo grade III (those requiring surgical, endoscopic, or radiologic intervention) or above are regarded as major complications.

Secondary Outcome Measures

Name	Time	Method
Operative time	Up to 1 month
Operative blood loss	Up to 1 month
Pain scores on a visual analog scale	Up to 1 month
Analgesic requirement	Up to 1 month
Length of hospital stay	Up to 1 month
Resection margin positivity for malignancy	Up to 1 month
Number of lymph nodes harvested	Up to 1 month
Anal continence after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)	Up to 12 months	The Cleveland Clinic Incontinence Score or Wexner's Score is the most common score used to determine the severity of incontinence before and after surgery for anal incontinence. The scoring system takes into account the type and frequency of incontinence, and the extent to which it alters the patient's life. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that may range from 0 to 20. Higher scores indicate higher levels of incontinence.
Male sexual function after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)	Up to 12 months	IIEF-5 is an abridged five-item version of the 15-item International Index of Erectile Function (IIEF) which is used to diagnose the presence and severity of erectile dysfunction. This questionnaire consists of only five questions and each IIEF-5 item is scored on a five-point ordinal scale where lower values represent poorer sexual function. Thus, a response of 0 for a question is considered the least functional, whereas a response of 5 is considered the most functional. The possible scores for the IIEF-5 range from 1 to 25 (one question has scores of 1-5), and a score above 21 is considered as normal erectile function and at or below this cutoff, erectile dysfunction.
Urinary function after surgery, measured by the International Prostate Symptom Score (IPSS)	Up to 12 months	IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Trial Locations

Locations (1)

Prince of Wales Hospital, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, China