Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures

N/AActive Not RecruitingNCT05457244

Chang Gung Memorial Hospital30 enrolled

Overview

The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option. All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

Colorectal surgery using the da Vinci SP System will be performed via the umbilicus, McBurney's site or the reverse McBurney's site depending on the sites of lesion. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Pathological confirm of colon or rectal cancer * Clinical stage I-III * Patient is a candidate for minimally invasive right hemicolectomy or anterior resection. * ASA ≤3 * Performance status: ECOG 0-1 Exclusion Criteria: * Emergency surgery * Patient has metastatic disease * Patient has a bleeding or clotting disorder * Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements * Previous laparotomy history * Patient unable to provide informed consent * Patient is pregnant * BMI 35.0 or higher

Outcomes

Primary Outcomes

Success rate (%)

Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure.