Clinical trial · Interventional
Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| single-port robotic surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participant arm
- interventionNames
- Device: single-port robotic surgery
Primary outcomes (1)
- measure
- Success rate (%)
- timeFrame
- immediately after the surgery
- description
- 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.
Secondary outcomes (16)
- measure
- Perioperative Parameters:Incision length
- timeFrame
- immediately after the surgery
- description
- Incision length
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- RESULTMarks 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. PMID 28707106
- RESULTKneist 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. PMID 32394173
- RESULTLin 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. PMID 24117036
- RESULTLu 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. PMID 21914101
- RESULTLai 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. PMID 25079975
- RESULTKim 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. PMID 27592126