This is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Robot assisted single-port rectal resection, colectomy, partial gastrectomy, appendectomy and cholecystectomy via the single-port configuration
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGConversion rate
The proportion of converted to laparotomy, laparoscopic surgery and added ≥ 2 trocars
Time frame: intraoperative
Operative time
Operative time(minutes)
Time frame: intraoperative
Intraoperative blood loss
Estimated blood loss(milliliters,ml)
Time frame: intraoperative
Length of stay
The postoperative day when patients complied with the predefined discharge criteria(days after surgery)
Time frame: 1-14 days after surgery
Early morbidity rate
morbidity rate 30 days after surgery
Time frame: 30 days after surgery
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
Time frame: 1-14 days after surgery
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