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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05486299
Collaborator
(none)
10
1
1
11.8
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robotic assisted single-port general surgery
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery: An Exploratory Study of a Novel Robotic System
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Conversion rate [intraoperative]

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

Secondary Outcome Measures

  1. Operative time [intraoperative]

    Operative time(minutes)

  2. Intraoperative blood loss [intraoperative]

    Estimated blood loss(milliliters,ml)

  3. Length of stay [1-14 days after surgery]

    The postoperative day when patients complied with the predefined discharge criteria(days after surgery)

  4. Early morbidity rate [30 days after surgery]

    morbidity rate 30 days after surgery

  5. Incision healing [1-14 days after surgery]

    Incision healing grade at discharge. Grade A: well healed; Grade B: incision with inflammatory reaction but no suppuration; Grade C: incision cracked and suppurating

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai China 201801

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhao Ren, Director, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05486299
Other Study ID Numbers:
  • RASIS-01
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhao Ren, Director, Ruijin Hospital

Study Results

No Results Posted as of Aug 5, 2022