A randomized clinical trial of Da Vinci robot VS laparoscopic radical resection for colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2663935 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:PurposeThis study aims (1) to investigate the feasibility of robot-assisted penetrating keratoplasty (PK) using the new Da Vinci Xi Surgical System and (2) to report what we believe to be the first use of this system in experimental eye surgery.MethodsRobot-assisted PK procedures were performed on human corneal transplants using the Da Vinci Xi Surgical System. After an 8-mm corneal trephination, four interrupted sutures and one 10.0 monofilament running suture were made. For each procedure, duration and successful completion of the surgery as well as any unexpected events were assessed. The depth of the corneal sutures was checked postoperatively using spectral-domain optical coherence tomography (SD-OCT).ResultsRobot-assisted PK was successfully performed on 12 corneas. The Da Vinci Xi Surgical System provided the necessary dexterity to perform the different steps of surgery. The mean duration of the procedures was 43.4 ± 8.9 minutes (range: 28.5-61.1 minutes). There were no unexpected intraoperative events. SD-OCT confirmed that the sutures were placed at the appropriate depth.ConclusionsWe confirm the feasibility of robot-assisted PK with the new Da Vinci Surgical System and report the first use of the Xi model in experimental eye surgery. Operative time of robot-assisted PK surgery is now close to that of conventional manual surgery due to both improvement of the optical system and the presence of microsurgical instruments.Translational relevanceExperimentations will allow the advantages of robot-assisted microsurgery to be identified while underlining the improvements and innovations necessary for clinical use.
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Project description: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
| 2741643 | ecrin-mdr-crc
Project description:Interventions: The intervention in the RoboSTER trial is the use of the da Vinci Xi surgical robot to resect advanced or recurrent abdominal tumours (intervention name: robot-assisted multivisceral complete soft tissue extended resection). Intra-corporeal abdominal tumour resection (ICATR) involves performing resection using the Da Vinci Xi Surgical Robot’s arms internally, within the body. The majority of the surgery is performed by a colorectal surgeon, however urological surgeons and gynaecological surgeons are often involved and perform specialty specific procedures as parts of the overall surgery (ie: a urologist may perform a radical cystectomy). Abdominal tumour resection involves excision of the tumour and associated attached viscera, this may include bowel, and genitourinary organs. The surgical approach for ICATR follows standardised oncological principles to obtain clear surgical margins and appropriate resection of draining lymph node tissue, as performed for the traditional open approach (please see Comparator/Control Treatment section). The use of the robotic device will be confined to the instrument’s limitations, all remaining components of the surgery will be performed via routine practice. Reconstruction of gastrointestinal and urinary systems will be undertaken using a minimally invasive approach. The approximate duration of the intervention will be 13 hours, however this depends on each individual case. Adherence to the intervention is monitored by patient surgical case reports within electronic medical records and intra-operative surgical forms.
Primary outcome(s): Safety of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Safety of robotic surgery will be measured by the overall 30-day complication rate, calculated from the time surgery begins. Clavien-Dindo Grading System will be used to determine the 30-day complication rate. Complications will be collected by surgeon completed postoperative clinical data form alongside electronic medical records.
Note: all primary outcomes have equal weighting.[30 day time period, from when surgery commences.];Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Feasibility will be determined firstly by the cumulative time taken for eligible patient recruitment to the intervention. The eligibility date will be collected from patient consultations (screening form) and the trial inclusion date from the date of consent (consent form).[Time from first eligible consultation with surgeon until signing of the consent form for inclusion in the research trial.];Feasibility of Robotic Assisted Complete Multivisceral Soft Tissue Extended Resection.
Feasibility will be determined secondly by treatment retention, defined as the proportion of patients to not cross over to conventional open surgery (pre-operatively) in the absence of any clinical indication. Treatment retention will be collected from patient surgical records and intraoperative clinical data forms.[Peri/intra-operative]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy
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Project description:Purpose:To report an initial single-surgeon experience with single-port robot-assisted radical prostatectomy (SP-RARP) using the da Vinci SP surgical system (Intuitive Surgical, USA). Materials and Methods:Between December 2018 and October 2019, a single surgeon performed SP-RARP in 20 patients with prostate cancer. SP-RARP was performed using the conventional approach through an umbilical port with a GelPOINT access system (Applied Medical, USA) and an additional assist port. During surgery, the camera was placed in the 6- or 12-o'clock position, and a traction arm was placed in the counterpart position for upward or downward traction. Clinicopathologic data, perioperative data, and short-term surgical outcomes were analyzed. Results:Of 20 patients, 45% of patients had pT3 or greater disease and 45% had Gleason grade 4 to 5, respectively. In 11 patients that underwent lymph node dissection, the median number of lymph nodes removed was 19 (interquartile range [IQR], 14-22). Median operative time was 245 minutes (IQR, 200-255), and median console time was 190 minutes (IQR, 165-210). Median blood loss was 200 mL (IQR, 150-300 mL), and there were no intraoperative complications or open conversion. In 10 patients with a follow-up period longer than 3 months, one patient experienced biochemical recurrence, and all patients required 0 to 1 pads per day. Of seven patients that were potent before surgery, four recovered erectile function sufficient for intercourse. Conclusions:Our report shows the safety and feasibility of SP-RARP, and that the associated surgical outcomes with short-term follow-up are satisfactory.
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Project description:BackgroundThis study sought to evaluate the impact of a da Vinci Xi surgical robot on perioperative outcomes after pulmonary resections.MethodsA retrospective analysis of prospectively collected STS data was performed at a single institution for patients who underwent elective lung resections from 2012 to 2019. Patient outcomes were compared at three different time periods: before the adoption of the robot technology (predominately VATS), during the initial robot experience (the first 18 months), and after the mature robot experience (the second 18 months). Univariate and multivariate logistic regression modeling was performed to determine the factors associated with perioperative complications.ResultsFive hundred and four patients underwent pulmonary resection between the three time periods: 220 patients (43.7%) had surgery prior to the first use of the robot (predominately VATS), 126 patients (25%) had surgery during the initial experience with robot, and 158 patients (31.1%) had surgery during the mature robot experience. There were significantly less post-operative complications (15.2% vs. 34.9% vs. 39.1%, P<0.001), shorter median length of stay (2 vs. 3 vs. 4 days, P<0.001), and lower hospital readmission rates (1.9% vs. 4% vs. 11.8%, P<0.001) in the mature robot period compared to the initial robot period and the predominately VATS period, respectively. Multivariate analysis showed that the robot was associated with a decrease in post-operative complications (OR 0.36; 95% CI, 0.23-0.57, P<0.001).ConclusionsThe adoption of a da Vinci Xi robot in our institution was associated with improved outcomes in patients having pulmonary resections.
| S-EPMC7399389 | biostudies-literature