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

General Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486299
• Other study ID #: RASIS-01
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: Ruijin Hospital
• Contact: Ren Zhao, MD, PHD
• Phone: +8618917762018
• Email: zhaorensurgeon[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years < age =75 years

• Suitable for minimally invasive surgery

• 18.5=BMI=28 kg/m2

• ASA score is ?-?

• 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.

Related Conditions & MeSH terms

• General Surgery

Intervention

Procedure:
• Robotic assisted single-port general surgery
Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	The proportion of converted to laparotomy, laparoscopic surgery and added = 2 trocars	intraoperative
Secondary	Operative time	Operative time(minutes)	intraoperative
Secondary	Intraoperative blood loss	Estimated blood loss(milliliters,ml)	intraoperative
Secondary	Length of stay	The postoperative day when patients complied with the predefined discharge criteria(days after surgery)	1-14 days after surgery
Secondary	Early morbidity rate	morbidity rate 30 days after surgery	30 days after surgery
Secondary	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