Clinical trial NCT05486299: Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Surgery
Keywords: robotic surgery
robotic assisted single-incision surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Conversion rate
timeFrame: intraoperative
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
measure: Length of stay
timeFrame: 1-14 days after surgery
measure: Early morbidity rate
timeFrame: 30 days after surgery
measure: Incision healing
timeFrame: 1-14 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
name: Ren Zhao, MD, PHD
role: STUDY_CHAIR
References:
citation: 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.
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.