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1,294 result(s) for "Robotic Surgical Procedures - adverse effects"
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Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer: a multi-institutional prospective single-arm study
BackgroundRobotic gastrectomy (RG) for gastric cancer (GC) has been increasingly performed for a decade; however, evidence for its use as a standard treatment has not yet been established. The present study aimed to determine the safety, feasibility, and effectiveness of RG for GC.MethodsThis multi-institutional, single-arm prospective study, which included 330 patients from 15 institutions, was designed to compare morbidity rate of RG with that of a historical control (conventional laparoscopic gastrectomy, LG). This trial was approved for Advanced Medical Technology (“Senshiniryo”) B. The included patients were operable patients with cStage I/II GC. The primary endpoint was morbidity (Clavien–Dindo Grade ≥ IIIa). The specific hypothesis was that RG could reduce the morbidity rate to less than half of that with LG (6.4%). A sample size of 330 was considered sufficient (one-sided alpha 0.05, power 80%).ResultsAmong the 330 study patients, the protocol treatment was suspended in 4 patients. Thus, 326 patients fully enrolled and completed the study. The median patient age and BMI were 66 years and 22.4 kg/m2, respectively. Distal gastrectomy was performed in 253 (77.6%) patients. The median operative time and estimated blood loss were 313 min and 20 mL, respectively. No 30-day mortality was seen, and morbidity showed a significant reduction to 2.45% with RG (p = 0.0018).ConclusionsRG for cStage I/II GC is safe and feasible. It may be effective in reducing morbidity with LG.
Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial
Radical cystectomy is the surgical standard for invasive bladder cancer. Robot-assisted cystectomy has been proposed to provide similar oncological outcomes with lower morbidity. We aimed to compare progression-free survival in patients with bladder cancer treated with open cystectomy and robot-assisted cystectomy. The RAZOR study is a randomised, open-label, non-inferiority, phase 3 trial done in 15 medical centres in the USA. Eligible participants (aged ≥18 years) had biopsy-proven clinical stage T1–T4, N0–N1, M0 bladder cancer or refractory carcinoma in situ. Individuals who had previously had open abdominal or pelvic surgery, or who had any pre-existing health conditions that would preclude safe initiation or maintenance of pneumoperitoneum were excluded. Patients were centrally assigned (1:1) via a web-based system, with block randomisation by institution, stratified by type of urinary diversion, clinical T stage, and Eastern Cooperative Oncology Group performance status, to receive robot-assisted radical cystectomy or open radical cystectomy with extracorporeal urinary diversion. Treatment allocation was only masked from pathologists. The primary endpoint was 2-year progression-free survival, with non-inferiority established if the lower bound of the one-sided 97·5% CI for the treatment difference (robotic cystectomy minus open cystectomy) was greater than −15 percentage points. The primary analysis was done in the per-protocol population. Safety was assessed in the same population. This trial is registered with ClinicalTrials.gov, number NCT01157676. Between July 1, 2011, and Nov 18, 2014, 350 participants were randomly assigned to treatment. The intended treatment was robotic cystectomy in 176 patients and open cystectomy in 174 patients. 17 (10%) of 176 patients in the robotic cystectomy group did not have surgery and nine (5%) patients had a different surgery to that they were assigned. 21 (12%) of 174 patients in the open cystectomy group did not have surgery and one (1%) patient had robotic cystectomy instead of open cystectomy. Thus, 302 patients (150 in the robotic cystectomy group and 152 in the open cystectomy group) were included in the per-protocol analysis set. 2-year progression-free survival was 72·3% (95% CI 64·3 to 78·8) in the robotic cystectomy group and 71·6% (95% CI 63·6 to 78·2) in the open cystectomy group (difference 0·7%, 95% CI −9·6% to 10·9%; pnon-inferiority=0·001), indicating non-inferiority of robotic cystectomy. Adverse events occurred in 101 (67%) of 150 patients in the robotic cystectomy group and 105 (69%) of 152 patients in the open cystectomy group. The most common adverse events were urinary tract infection (53 [35%] in the robotic cystectomy group vs 39 [26%] in the open cystectomy group) and postoperative ileus (33 [22%] in the robotic cystectomy group vs 31 [20%] in the open cystectomy group). In patients with bladder cancer, robotic cystectomy was non-inferior to open cystectomy for 2-year progression-free survival. Increased adoption of robotic surgery in clinical practice should lead to future randomised trials to assess the true value of this surgical approach in patients with other cancer types. National Institutes of Health National Cancer Institute.
Robot-Assisted Radical Hysterectomy in Cervical Carcinoma: The Belgian Experience
ObjectiveThe purpose of this study was to report the experience and oncological outcome of robot-assisted radical hysterectomies (RRHs) for cervical cancer performed in Belgium.MethodsPatients undergoing RRH for cervical cancer (n = 109) were prospectively collected between July 2007 and April 2014 in the 5 Belgian centers performing RRH for cervical cancer.ResultsThe median age of the patients was 46 years (range, 31–80 years). Histological types included squamous cell carcinoma in 61 patients, adenocarcinoma in 22 patients, adenosquamous in 8 patients, endometrioid carcinoma in 2 patients, and other types (n = 16). The International Federation of Gynecology and Obstetrics stage distribution was IA (n = 9), stage IB1 (n = 71), stage IB2 (n = 4), stage II (n = 24), and unknown (n = 1). Twenty-four patients received adjuvant therapy, 17 patients underwent radiochemotherapy, and 7 underwent adjuvant radiation. Eighteen patients relapsed, and 5 died of disease. The median follow-up was 27.5 months (range, 3–82 months). The 2- and 5-year overall survivals were 96% and 89%, respectively. The 2- and 5-year disease-free survivals (DFSs) were 88% and 72%, respectively. The 2-year DFS per stage was 100% for IA, 88% for IB1, 100% for IB2, and 83% for II. The 5-year DFS per stage was 100% for stage IA and 75% for IB1. The complications were as expected for radical hysterectomy.ConclusionsThis series confirms the feasibility and safety of RRH not only in cervical cancer stage IA to IB1, but also after neoadjuvant chemotherapy in stage IB2 to IIB.
Multi-Modal Haptic Feedback for Grip Force Reduction in Robotic Surgery
Minimally invasive robotic surgery allows for many advantages over traditional surgical procedures, but the loss of force feedback combined with a potential for strong grasping forces can result in excessive tissue damage. Single modality haptic feedback systems have been designed and tested in an attempt to diminish grasping forces, but the results still fall short of natural performance. A multi-modal pneumatic feedback system was designed to allow for tactile, kinesthetic, and vibrotactile feedback, with the aims of more closely imitating natural touch and further improving the effectiveness of HFS in robotic surgical applications and tasks such as tissue grasping and manipulation. Testing of the multi-modal system yielded very promising results with an average force reduction of nearly 50% between the no feedback and hybrid (tactile and kinesthetic) trials (p < 1.0E-16). The multi-modal system demonstrated an increased reduction over single modality feedback solutions and indicated that the system can help users achieve average grip forces closer to those normally possible with the human hand.
Robotic versus laparoscopic ventral hernia repair: multicenter, blinded randomized controlled trial
AbstractObjectiveTo determine whether robotic ventral hernia repair is associated with fewer days in the hospital 90 days after surgery compared with laparoscopic repair.DesignPragmatic, blinded randomized controlled trial.SettingMultidisciplinary hernia clinics in Houston, USA.Participants124 patients, deemed appropriate candidates for elective minimally invasive ventral hernia repair, consecutively presenting from April 2018 to February 2019.InterventionsRobotic ventral hernia repair (n=65) versus laparoscopic ventral hernia repair (n=59).Main outcome measuresThe primary outcome was number of days in hospital within 90 days after surgery. Secondary outcomes included emergency department visits, operating room time, wound complications, hernia recurrence, reoperation, abdominal wall quality of life, and costs from the healthcare system perspective. Outcomes were pre-specified before data collection began and analyzed as intention to treat.ResultsPatients from both groups were similar at baseline. Ninety day follow-up was completed in 123 (99%) patients. No evidence was seen of a difference in days in hospital between the two groups (median 0 v 0 days; relative rate 0.90, 95% confidence interval 0.37 to 2.19; P=0.82). For secondary outcomes, no differences were noted in emergency department visits, wound complications, hernia recurrence, or reoperation. However, robotic repair had longer operative duration (141 v 77 min; mean difference 62.89, 45.75 to 80.01; P≤0.001) and increased healthcare costs ($15 865 (£12 746; €14 125) v $12 955; cost ratio 1.21, 1.07 to 1.38; adjusted absolute cost difference $2767, $910 to $4626; P=0.004). Among patients with robotic ventral hernia repair, two had an enterotomy compared none with laparoscopic repair. The median one month postoperative improvement in abdominal wall quality of life was 3 with robotic ventral hernia repair compared with 15 following laparoscopic repair.ConclusionThis study found no evidence of a difference in 90 day postoperative hospital days between robotic and laparoscopic ventral hernia repair. However, robotic repair increased operative duration and healthcare costs.Trial registrationClinicaltrials.gov NCT03490266.
Technique, Results, and Complications Related to Robot-Assisted Stereoelectroencephalography
ABSTRACT BACKGROUND: Robot-assisted stereoelectroencephalography (SEEG) may represent a simplified, precise, and safe alternative to the more traditional SEEG techniques. OBJECTIVE: To report our clinical experience with robotic SEEG implantation and to define its utility in the management of patients with medically refractory epilepsy. METHODS: The prospective observational analyses included all patients with medically refractory focal epilepsy who underwent robot-assisted stereotactic placement of depth electrodes for extraoperative brain monitoring between November 2009 and May 2013. Technical nuances of the robotic implantation technique are presented, as well as an analysis of demographics, time of planning and procedure, seizure outcome, in vivo accuracy, and procedure-related complications. RESULTS: One hundred patients underwent 101 robot-assisted SEEG procedures. Their mean age was 33.2 years. In total, 1245 depth electrodes were implanted. On average, 12.5 electrodes were implanted per patient. The time of implantation planning was 30 minutes on average (range, 15-60 minutes). The average operative time was 130 minutes (range, 45-160 minutes). In vivo accuracy (calculated in 500 trajectories) demonstrated a median entry point error of 1.2 mm (interquartile range, 0.78-1.83 mm) and a median target point error of 1.7 mm (interquartile range, 1.20-2.30 mm). Of the group of patients who underwent resective surgery (68 patients), 45 (66.2%) gained seizure freedom status. Mean follow-up was 18 months. The total complication rate was 4%. CONCLUSION: The robotic SEEG technique and method were demonstrated to be safe, accurate, and efficient in anatomically defining the epileptogenic zone and subsequently promoting sustained seizure freedom status in patients with difficult-to-localize seizures.
Comparison of retropubic, laparoscopic and robotic radical prostatectomy: who is the winner?
PurposeThis study is a systematic analysis of the evidence regarding oncological, perioperative and postoperative outcomes and the cost of open retropubic radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP) and robotic-assisted laparoscopic radical prostatectomy (RALP).MethodsSummary data was abstracted from 104 original research articles representing 227,400 patients. PubMed/Medline, Scopus, Google Scholar, EMBASE and the Cochrane Library were reviewed in December 2016. A total of 104 publications were selected for inclusion. The primary outcomes were positive surgical margin (PSM) and major complication rate according to Clavien classifications. Secondary outcomes were operative time, length of hospital stay, estimated blood loss, transfusions, conversions, rate of post-operative erectile dysfunction and incontinence and total cost of procedure.ResultsORP had a significantly higher rate than RALP for PSM (OR: 1.18; 95% CI 1.05–1.32; p = 0.004), but the rate of PSM was not significantly different between ORP versus LRP (OR: 1.37; 95% CI 0.88–2.14; p = 0.17) and RALP versus LRP (OR: 0.83; 95% CI 0.40–1.72; p = 0.62). The major Clavien complication rate was significantly different between ORP and RALP (OR: 2.14; 95% CI 1.24–3.68; p = 0.006). Estimated blood loss, transfusions and length of hospital stay were low for RALP, moderate for LRP and high for ORP. The rate of erectile dysfunction (OR: 2.58; 95% CI 1.77–3.75; p < 0.001) and incontinence (OR: 3.57; 95% CI 2.28–5.58; p < 0.001) were significantly lower after RALP than LRP and equivalent for other comparisons. Total cost was highest for RALP, followed by LRP and ORP.ConclusionsFor PSM and peri- and post-operative complications, RALP showed better results than ORP and LRP. In the context of the biases between the studies, one should interpret the results with caution.
Robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis of randomized controlled trials
PurposeSeveral studies have revealed that robot-assisted technique might improve the pedicle screw insertion accuracy, but owing to the limited sample sizes in the individual study reported up to now, whether or not robot-assisted technique is superior to conventional freehand technique is indefinite. Thus, we performed this systematic review and meta-analysis based on randomized controlled trials to assess which approach is better.MethodsElectronic databases including PubMed, EMBASE, CENTRAL, ISI Web of Science, CNKI and WanFang were systematically searched to identify potentially eligible articles. Main endpoints containing the accuracy of pedicle screw implantation and proximal facet joint violation were evaluated as risk ratio (RR) and the associated 95% confidence intervals (95% CIs), while radiation exposure and surgical duration were presented as mean difference (MD) or standard mean difference (SMD). Meta-analyses were performed using RevMan 5.3 software.ResultsSix studies involving 158 patients (688 pedicle screws) in robot-assisted group and 148 patients (672 pedicle screws) in freehand group were identified matching our study. The Grade A accuracy rate in robot-assisted group was superior to freehand group (RR 1.03, 95% CI 1.00, 1.06; P = 0.04), but the Grade A + B accuracy rate did not differ between the two groups (RR 1.01, 95% CI 0.99, 1.02; P = 0.29). With regard to proximal facet joint violation, the combined results suggested that robot-assisted group was associated with significantly fewer proximal facet joint violation than freehand group (RR 0.07, 95% CI 0.01, 0.55; P = 0.01). As was the radiation exposure, our findings suggested that robot-assisted technique could significantly reduce the intraoperative radiation time (MD − 12.38, 95% CI − 17.95, − 6.80; P < 0.0001) and radiation dosage (SMD − 0.64, 95% CI − 0.85, − 0.43; P < 0.00001). But the overall surgical duration was longer in robot-assisted group than conventional freehand group (MD 20.53, 95% CI 5.17, 35.90; P = 0.009).ConclusionsThe robot-assisted technique was associated with equivalent accuracy rate of pedicle screw implantation, fewer proximal facet joint violation, less intraoperative radiation exposure but longer surgical duration than freehand technique. Powerful evidence relies on more randomized controlled trials with high quality and larger sample size in the future.
Robotic-assisted versus laparoscopic left pancreatectomy at a high-volume, minimally invasive center
IntroductionWhile minimally invasive left pancreatectomy has become more widespread and generally accepted over the last decade, opinions on modality of minimally invasive approach (robotic or laparoscopic) remain mixed with few institutions performing a significant portion of both operative approaches simultaneously.Methods247 minimally invasive left pancreatectomies were retrospectively identified in a prospectively maintained institutional REDCap™ database, 135 laparoscopic left pancreatectomy (LLP) and 108 robotic-assisted left pancreatectomy (RLP). Demographics, intraoperative variables, postoperative outcomes, and OR costs were compared between LLP and RLP with an additional subgroup analysis for procedures performed specifically for pancreatic adenocarcinoma (35 LLP and 23 RLP) focusing on pathologic outcomes and 2-year actuarial survival.ResultsThere were no significant differences in preoperative demographics or indications between LLP and RLP with 34% performed for chronic pancreatitis and 23% performed for pancreatic adenocarcinoma. While laparoscopic cases were faster (p < 0.001) robotic cases had a higher rate of splenic preservation (p < 0.001). Median length of stay was 5 days for RLP and LLP, and rate of clinically significant grade B/C pancreatic fistula was approximately 20% for both groups. Conversion rates to laparotomy were 4.3% and 1.8% for LLP and RLP approaches respectively. RLP had a higher rate of readmission (p = 0.035). Pathologic outcomes and 2-year actuarial survival were similar between LLP and RLP. LLP on average saved $206.67 in OR costs over RLP.ConclusionsThis study demonstrates that at a high-volume center with significant minimally invasive experience, both LLP and RLP can be equally effective when used at the discretion of the operating surgeon. We view the laparoscopic and robotic platforms as tools for the modern surgeon, and at our institution, given the technical success of both operative approaches, we will continue to encourage our surgeons to approach a difficult operation with their tool of choice.Graphical abstract
Comparative clinical outcomes of robot-assisted liver resection versus laparoscopic liver resection: A meta-analysis
As an emerging technology, robot-assisted surgical system has some potential merits in many complicated endoscopic procedures compared with laparoscopic surgery. But robot-assisted liver resection is still a controversial problem on its advantages compared with laparoscopic liver resection. We aimed to perform the meta-analysis to assess and compare the clinical outcomes of robot-assisted and laparoscopic liver resection. We searched PubMed, Cochrane Library, Embase databases, Clinicaltrials, and Opengrey through March 24, 2020, including references of qualifying articles. English-language, original investigations in humans about robot-assisted and laparoscopic hepatectomy were included. Titles, abstracts, and articles were reviewed by at least 2 independent readers. Continuous and dichotomous variables were compared by the weighted mean difference (WMD) and odds ratio (OR), respectively. Of 936 titles identified in our original search, 28 articles met our criteria, involving 3544 patients. Compared with laparoscopy, the robot-assisted groups had longer operative time (WMD: 36.93; 95% CI, 19.74-54.12; P < 0.001), lower conversion rate (OR: 0.63; 95% CI, 0.46-0.87; P = 0.005), higher transfusion rate (WMD: 2.39; 95% CI, 1.51-3.76; P < 0.001) and higher total cost (WMD:0.49; 95% CI, 0.42-0.55; P < 0.001). In addition, the baseline characteristics of patients about largest tumor size was larger (WMD: 0.36; 95% CI, 0.16-0.56; P < 0.001) and malignant lesions rate was higher (WMD: 1.50; 95% CI, 1.21-1.86; P < 0.001) in the robot-assisted versus laparoscopic hepatectomy. The subgroup analysis of minor hepatectomy showed robot-assisted was associated with longer operative time (WMD: 36.00; 95% CI, 12.59-59.41; P = 0.003), longer length of stay (WMD: 0.51; 95% CI, 0.02-1.01; p = 0.04) and higher total cost (WMD: 0.48; 95% CI, 0.25-0.72; P < 0.001) (Table 3); while the subgroup analysis of major hepatectomy showed robot-assisted was associated with lower estimated blood loss (WMD: -122.43; 95% CI, -151.78--93.08; P < 0.001). Our meta-analysis revealed that robot-assisted was associated with longer operative time, lower conversion rate, higher transfusion rate and total cost, and robot-assisted has certain advantages in major hepatectomy compared with laparoscopic hepatectomy.