Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery
- Conditions
- General Surgery
- Interventions
- Procedure: Robotic assisted single-port general surgery
- Registration Number
- NCT05486299
- Lead Sponsor
- Ruijin Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-port Endoscopic Surgical System Robotic assisted single-port general surgery 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.
- Primary Outcome Measures
Name Time Method Conversion rate intraoperative The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars
- Secondary Outcome Measures
Name Time Method Operative time intraoperative Operative time（minutes）
Intraoperative blood loss intraoperative Estimated blood loss（milliliters，ml）
Length of stay 1-14 days after surgery The postoperative day when patients complied with the predefined discharge criteria（days after surgery）
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
Early morbidity rate 30 days after surgery morbidity rate 30 days after surgery
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China