Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery

Study Overview
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Brief Summary
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This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.

Detailed Description
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Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. It has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. However, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. Therefore, robotic assisted single-port surgery is attracting increasing attention. This study is to investigate the safety of a novel single-port robotic system for general surgery.

Official Title
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Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System

Conditions
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General Surgery

Intervention / Treatment
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* Procedure: Robotic assisted single-port general surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years < age ≤75 years Suitable for minimally invasive surgery 18.5≤BMI≤28 kg/m2 ASA score is Ⅰ-Ⅲ Informed consent Colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed cT3N0M0 with a maximum diameter of ≤4 cm located above the peritoneal reflection. Partial gastrectomy: gastric stromal tumor, gastric giant ulcer. Appendectomy: chronic appendicitis. Cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (> 1 cm). Exclusion Criteria: With other malignancies or a previous history of other malignancies Undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial With active tuberculosis With severe systemic disease With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders. With severe allergies and suspected or established alcohol, drug or substance addiction Patients who are immunodeficiency virus (HIV) antibody positive; hepatitis B surface antigen (HbsAg) positive and have a hepatitis B virus DNA (HBV-DNA) copy number above the lower limit of detection or normal range; hepatitis C virus (HCV) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator. Emergency surgery Women who are pregnant, breastfeeding or planning to become pregnant during the trial Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-port Endoscopic Surgical System<br>A novel robotic surgical system that can be configured for multi-port, single-port, or hybrid-port procedures. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. | Procedure: Robotic assisted single-port general surgery<br>* Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time（minutes） | intraoperative | 
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | intraoperative | 
| Length of stay | The postoperative day when patients complied with the predefined discharge criteria（days after surgery） | 1-14 days after surgery | 
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days after surgery | 
| Incision healing | Incision healing grade at discharge. Grade A: well healed; Grade B: incision with inflammatory reaction but no suppuration; Grade C: incision cracked and suppurating | 1-14 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery, robotic assisted single-incision surgery