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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-port robotic surgery | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Parameters:Incision length | Incision length | immediately after the surgery |
| Perioperative Parameters:Time of surgery | Time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Chang Lu, MD | Kaohsiung Chang Gung Memorial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28707106 | Result | 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. | |
| 32394173 | Result | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| immediately after the surgery |
| Perioperative Parameters:Total operative time | Total operative time | immediately after the surgery |
| Perioperative Parameters:Robotic console time | Robotic console time | immediately after the surgery |
| Perioperative Parameters: Blood transfusions | Blood transfusion amount | immediately after the surgery |
| Perioperative Parameters: Estimated blood loss | Estimated blood loss | immediately after the surgery |
| Perioperative Parameters: Intra-operative Complications | Satava System | immediately after the surgery |
| Perioperative Parameters: Urine output | Urine output | immediately after the surgery |
| Perioperative Parameters: Type of anastomosis | How the anastomosis was performed and method of construction | immediately after the surgery |
| Postoperative Parameters:pain requirements | type, frequency, total amount of narcotics used postoperatively per day | Within 30days after the surgery |
| Postoperative Parameters:Pain score | NRS | Within 30days after the surgery |
| Postoperative Parameters:Time to tolerate diets | time to tolerate clear liquids and solid food | Within 30days after the surgery |
| Postoperative Parameters:Time to flatus | Time to flatus | Within 30days after the surgery |
| Postoperative Parameters:Time to discharge | Time to discharge | Within 30days after the surgery |
| Postoperative Parameters:Complications | Clavien-Dindo Classification | Within 30days after the surgery |
| Postoperative Parameters:Readmission and reoperation rate | Readmission and reoperation rate | Within 30days after the surgery |
| 24117036 | Result | 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. |
| 21914101 | Result | 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. |
| 25079975 | Result | 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. |
| 27592126 | Result | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |