Clinical trial NCT05457244: Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Official title: A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Colorectal Cancer
Robotic Surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2022-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Success rate (%)
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Perioperative Parameters:Incision length
timeFrame: immediately after the surgery
measure: Perioperative Parameters:Time of surgery
timeFrame: immediately after the surgery
measure: Perioperative Parameters:Total operative time
timeFrame: immediately after the surgery
measure: Perioperative Parameters:Robotic console time
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Blood transfusions
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Estimated blood loss
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Intra-operative Complications
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Urine output
timeFrame: immediately after the surgery
measure: Perioperative Parameters: Type of anastomosis
timeFrame: immediately after the surgery
measure: Postoperative Parameters:pain requirements
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Pain score
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Time to tolerate diets
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Time to flatus
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Time to discharge
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Complications
timeFrame: Within 30days after the surgery
measure: Postoperative Parameters:Readmission and reoperation rate
timeFrame: Within 30days after the surgery
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Kaohsiung Chang Gung Memorial
name: Chien-Chang Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marks J, Ng S, Mak T. Robotic transanal surgery (RTAS) with utilization of a next-generation single-port system: a cadaveric feasibility study. Tech Coloproctol. 2017 Jul;21(7):541-545. doi: 10.1007/s10151-017-1655-3. Epub 2017 Jul 14.
citation: Kneist W, Stein H, Rheinwald M. Da Vinci Single-Port robot-assisted transanal mesorectal excision: a promising preclinical experience. Surg Endosc. 2020 Jul;34(7):3232-3235. doi: 10.1007/s00464-020-07444-4. Epub 2020 May 11.
citation: Lin YM, Chen HH, Chen YJ, Chen PH, Lu CC. Single-incision laparoscopic colectomy using self-made glove port for benign colon diseases. J Laparoendosc Adv Surg Tech A. 2013 Nov;23(11):932-7. doi: 10.1089/lap.2013.0383. Epub 2013 Oct 11.
citation: Lu CC, Lin SE, Chung KC, Rau KM. Comparison of clinical outcome of single-incision laparoscopic surgery using a simplified access system with conventional laparoscopic surgery for malignant colorectal disease. Colorectal Dis. 2012 Apr;14(4):e171-6. doi: 10.1111/j.1463-1318.2011.02825.x.
citation: Lai WH, Lin YM, Lee KC, Chen HH, Chen YJ, Lu CC. The application of McBurney's single-incision laparoscopic colectomy alleviates the response of patients to postoperative wound pain. J Laparoendosc Adv Surg Tech A. 2014 Sep;24(9):606-11. doi: 10.1089/lap.2014.0167. Epub 2014 Jul 31.
citation: Kim SJ, Choi BJ, Lee SC. Comparative analysis of outcomes after multiport and single-port laparoscopic colectomy in emergency situations: Is single-port laparoscopic colectomy safe and feasible? Asian J Surg. 2018 Jan;41(1):20-29. doi: 10.1016/j.asjsur.2016.07.008. Epub 2016 Aug 31.