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

NCT05486299 | Unknown DMC

• 1 other identifier: RASIS-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

General Surgery

Keywords

robotic surgery; robotic assisted single-incision surgery

Outcome Measures

Primary Outcomes (1)

• Conversion rate

  The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars

  intraoperative

Secondary Outcomes (5)

• Operative time

  intraoperative

• Intraoperative blood loss

  intraoperative

• Length of stay

  1-14 days after surgery

• Early morbidity rate

  30 days after surgery

• Incision healing

  1-14 days after surgery

Study Arms (1)

Single-port Endoscopic Surgical System

EXPERIMENTAL

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

Interventions

Robotic assisted single-port general surgery PROCEDURE

Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration

Single-port Endoscopic Surgical System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years \< age ≤75 years
• Suitable for minimally invasive surgery
• ≤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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 201801, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 30218263 BACKGROUND

• 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.

  PMID: 23052525 BACKGROUND

• Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612.

  PMID: 37526117 DERIVED

Study Officials

• Ren Zhao, MD, PHD

  Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Ren Zhao, MD, PHD

CONTACT

+8618917762018; zhaorensurgeon@aliyun.com

Kun Liu, MD

CONTACT

+8618121263082; lookiere@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: March 7, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)