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

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

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

Study Overview

• Status: Recruiting
• Conditions: General Surgery
• Intervention / Treatment: Procedure: Robotic assisted single-port general surgery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201801
    • Recruiting
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-port Endoscopic Surgical System; 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; Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Ren Zhao, MD, PHD, Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine

Publications and helpful links

General Publications

• Grochola LF, Soll C, Zehnder A, Wyss R, Herzog P, Breitenstein S. Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial. Surg Endosc. 2019 May;33(5):1482-1490. doi: 10.1007/s00464-018-6430-7. Epub 2018 Sep 14.
• Lim MS, Melich G, Min BS. Robotic single-incision anterior resection for sigmoid colon cancer: access port creation and operative technique. Surg Endosc. 2013 Mar;27(3):1021. doi: 10.1007/s00464-012-2549-0. Epub 2012 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: robotic surgery; robotic assisted single-incision surgery
• Other Study ID Numbers: RASIS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No