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Not yet recruiting NCT07255703

Thoracic Surgery by SHURUI Single-Port Surgical Robot

— Observational Thoracic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Device: Endoscopic Surgical System, SR-ENS-600.
Who it may be relevant to
Registry conditions: Thoracic Surgery. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Thoracic Surgery by SHURUI Single-Port Surgical Robot: A Prospective Single Centre Study

Overview

The introduction of single-port surgical robot has been a transformative breakthrough in the medical field, representing a significant advancement in minimally invasive procedures. One notable innovation is the SHURUI single-port surgical robot (SP), developed by Beijing Surgerii Robotics Company Limited. The SHURUI SP represents a cutting-edge technology in the field. This system features snake-like surgical instruments utilizing "dual continuum mechanism", which enables precise single-port procedures with wide range of motion and high load capacity. The SHURUI SP has been cleared by the National Medical Products Administration (NMPA) of China for use in urology and gynecology and has completed clinical trials for general surgery and thoracic surgery. It is China's first and the world's second approved single-port surgical robot. Compared to multi-port surgical robots, it can provide patients with less trauma, fewer complications, and faster recovery. The SHURUI SP has also achieved significant breakthroughs in clinical applications. It conducted the world's first randomized controlled clinical trial on single-port robotic urologic surgery and introduced a series of innovative surgical paradigms. These include the world's first single-port sleeve lobectomy, single-port retroperitoneal adrenalectomy, single-port retroperitoneal partial nephrectomy, single-port distal gastrectomy (Billroth I anastomosis), and single-port total gastrectomy. Our centre is the first robotic surgical centre in Hong Kong since 2005. Over the years, investigators have established our centre to be one of the leading centre in Hong Kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures. In this study, investigators evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by SHURUI SP.

Interventions

  • Device Device: Endoscopic Surgical System, SR-ENS-600
    undergoing robotic thoracic surgery by the Endoscopic Surgical System, SR-ENS-600

Primary outcome measures

  • conversion rate [Time frame: 1 year + 1 month follow-up]
  • major peri-operative complication rate (Clavein-Dindo grading III or above) [Time frame: 1 year + 1 month follow-up]
Secondary outcome measures (11)
  • Operation time [Time frame: 1 year]
  • Estimated intraoperative blood loss (EBL) [Time frame: 1 year]
  • Length of hospital stay [Time frame: 1 year + 1 month follow-up]
  • Postoperative pain score [Time frame: 1 year + 1 month follow-up]
  • Blood transfusion rate [Time frame: 1 year]
  • The Surgeon Satisfaction Questionnaire [Time frame: 1 year+ 1 month follow-up]
  • Perioperative complication [Time frame: 1 year]
  • device defects incidence [Time frame: 1 year]
  • readmission rate within 30 days after surgery [Time frame: 1 month follow-up]
  • re-operation rate with 30 days after surgery [Time frame: 1 month follow-up]
  • Mortality within 30 days after surgery [Time frame: 1 month follow-up]

Eligibility criteria

Inclusion criteria

  • Age between 18 - 75 years;
  • Subjects need to undergo endoscopic surgery and meet one of the following indications for surgical treatment:
  • Lobectomy, segmentectomy wedge resection of lung: Clinically diagnosed resectable early stage non-small cell lung carcinoma; oligometastatic cancer to the lung;
  • Mediastinal mass resection: Clinically diagnosed mediastinal tumour (benign or malignant) that are indicated for resection;
  • Preoperative ASA grade: Grade I-III;
  • Subject voluntarily participates in the clinical trial, and agrees or his/her guardian agrees and signs the informed consent.

Exclusion criteria

  • Subjects with a previous history of thoracic surgery or other malignant tumor which, in the judgement of the investigator, make them unsuitable for enrolment;
  • Subjects with severe co-morbidities or organ dysfunction (heart, lung, liver, brain, kidney, etc.) or deemed too weak/ unsuitable for general anesthesia or operation;
  • Non-correctable coagulopathy and severe bleeding tendency；
  • Emergency surgery;
  • Severe obesity with BMI ≥30 kg/m2;
  • Subjects with severe allergic constitution, suspected or confirmed alcohol, drug addiction;
  • Other circumstances in which the investigator considered participation in this clinical trial inappropriate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

Identifiers

NCT: NCT07255703 · KF-600-3-583

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗