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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.

Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation. Supermicrosurgery is limited by the precision and dexterity of the surgeon’s hands. Robot assistance can help overcome these human limitations, thereby enabling a breakthrough in supermicrosurgery. We report the first-in-human study of robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform. A prospective randomized pilot study is conducted comparing robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA) in treating breast cancer-related lymphedema. We evaluate patient outcome at 1 and 3 months post surgery, duration of the surgery, and quality of the anastomosis. At 3 months, patient outcome improves. Furthermore, a steep decline in duration of time required to complete the anastomosis is observed in the robot-assisted group (33–16 min). Here, we report the feasibility of robot-assisted supermicrosurgical anastomosis in LVA, indicating promising results for the future of reconstructive supermicrosurgery. Reconstructive microsurgery is limited by the precision that human hands can achieve. Here, the authors demonstrate in a randomized clinical pilot trial the feasibility of robot-assisted supermicrosurgery using a dedicated microsurgical robot for the completion of lymphatico-venous anastomosis in the treatment of breast cancer-related lymphedema

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.

Laparoscopic/robotic radical hysterectomy has been historically considered oncologically equivalent to open radical hysterectomy for patients with early cervical cancer. However, a recent prospective randomized trial (Laparoscopic Approach to Cervical Cancer, LACC) has demonstrated significant inferiority of the minimally invasive approach. The aim of this study is to evaluate the oncologic outcomes of combined laparoscopic-vaginal radical hysterectomy. Between August 1994 and December 2018, patients with invasive cervical cancer were treated using minimally-invasive surgery at the Universities of Jena, Charité Berlin (Campus CCM and CBF) and Cologne and Asklepios Clinic Hamburg. 389 patients with inclusion criteria identical to the LACC trial were identified. In contrast to the laparoscopic/robotic technique used in the LACC trial, all patients in our cohort underwent a combined transvaginal-laparoscopic approach without the use of any uterine manipulator. A total of 1952 consecutive patients with cervical cancer were included in the analysis. Initial International Federation of Gynecology and Obstetrics (FIGO) stage was IA1 lymphovascular space invasion (LVSI+), IA2 and IB1/IIA1 in 32 (8%), 43 (11%), and 314 (81%) patients, respectively, and histology was squamous cell in 263 (68%), adenocarcinoma in 117 (30%), and adenosquamous in 9 (2%) patients. Lymphovascular invasion was confirmed in 106 (27%) patients. The median number of lymph nodes was 24 (range 2–86). Lymph nodes were tumor-free in 379 (97%) patients. Following radical hysterectomy, 71 (18%) patients underwent adjuvant chemoradiation or radiation. After a median follow-up of 99 (range 1–288) months, the 3-, 4.5-, and 10-year disease-free survival rates were 96.8%, 95.8%, and 93.1 %, and the 3-, 4.5-, and 10-year overall survival rates were 98.5%, 97.8%, and 95.8%, respectively. Recurrence location was loco-regional in 50% of cases with recurrence (n=10). Interestingly, 9/20 recurrences occurred more than 39 months after surgery. The combined laparoscopic-vaginal technique for radical hysterectomy with avoidance of spillage and manipulation of tumor cells provides excellent oncologic outcome for patients with early cervical cancer. Our retrospective data suggest that laparoscopic-vaginal surgery may be oncologically safe and should be validated in further randomized trials.

Background and Objectives: Performance of robot-assisted total knee arthroplasty (TKA) procedures has continued to increase in popularity. However, tourniquet use is necessary for longer periods of time in robot-assisted TKA than conventional manual TKA because the robot-assisted procedure requires an additional registration process. The use of tourniquets for long periods increases the risk of hidden blood loss and ischemic soft tissue injury in the lower extremity. The purpose of this study was to compare the value of performing robot-assisted TKA without the use of a tourniquet to that of performing this surgery with the use of a tourniquet. Parameters we assessed were blood loss, degree of postoperative thigh and knee pain, and occurrence of early post-operative complications. Materials and Methods: Data from 100 consecutive patients who underwent primary unilateral robot-assisted TKA between July 2024 and July 2025 were included in this study’s analyses. Patients were divided into three groups chronologically. The first 29 patients comprised group 1, the early tourniquet group; the next 30 patients were assigned to group 2, the no tourniquet group; and group 3 was the late tourniquet group and comprised the remaining 41 subjects. However, because allocation was chronological rather than randomized, the outcomes of later groups may partly reflect the surgeon’s accumulated experience (learning curve), which should be considered when interpreting the results. The primary outcome measure was estimated blood loss (EBL). The secondary outcome measures included transfusion rate, visual analog scale (VAS) pain scores for the knee and thigh on the third postoperative day, readmission rate due to surgical complications, superficial and deep infection rate, length of operation, and length of tourniquet use. Results: Group 2 participants, the no tourniquet participants, experienced significantly greater EBL on postoperative days (PODs) 1, 2, and 3 compared to the subjects assigned to groups 1 and 3 (p = 0.003, p < 0.001, and p = 0.005, respectively). However, there were no significant differences in transfusion rates (p = 0.290) among the 3 groups. VAS scores for knee and thigh pain were also not significantly different among the three groups (all p-values > 0.05). Three patients in group 1 (10.3%), one patient in group 2 (3.3%), and one patient in group 3 (2.4%) were readmitted for complications related to wound healing (p = 0.289). Additionally, two patients in group 1 developed superficial wound infections from which the causative bacteria were cultured. No infections were observed in the other groups (p = 0.082), however. Two patients in group 1 and two patients in group 2 experienced symptomatic deep vein thrombosis (DVT) (p = 0.235). No group 3 patients experienced DVT, and only one patient in group 2 was confirmed with DVT using an enhanced CT scan (p = 0.308). Group 3 patients had shorter lengths of surgery (p < 0.001) than group 1 and 2 patients and had shorter periods of tourniquet use (p = 0.034) than group 1 patients. Conclusions: Tourniquet non-use in robot-assisted TKA surgeries was associated with greater EBL in acute postoperative periods, but this finding was not accompanied by any change in transfusion rate. Tourniquet non-use was not clinically beneficial for reducing immediate postoperative thigh and knee pain or reducing the prevalence of early post-operative complications. Tourniquet use in robot-assisted TKA may be beneficial because of the advantages its use provides in maintaining a clear surgical field and in facilitating the cementing process.

BackgroundThe use of laparoscopic and robotic procedures has increased in general surgery. Minimally invasive robotic surgery has made tremendous progress in a relatively short period of time, realizing improvements for both the patient and surgeon. This has led to an increase in the use and development of robotic devices and platforms for general surgery. The purpose of this review is to explore current and emerging surgical robotic technologies in a growing and dynamic environment of research and development.MethodsThis review explores medical and surgical robotic endoscopic surgery and peripheral technologies currently available or in development. The devices discussed here are specific to general surgery, including laparoscopy, colonoscopy, esophagogastroduodenoscopy, and thoracoscopy. Benefits and limitations of each technology were identified and applicable future directions were described.ResultsA number of FDA-approved devices and platforms for robotic surgery were reviewed, including the da Vinci Surgical System, Sensei X Robotic Catheter System, FreeHand 1.2, invendoscopy E200 system, Flex® Robotic System, Senhance, ARES, the Single-Port Instrument Delivery Extended Research (SPIDER), and the NeoGuide Colonoscope. Additionally, platforms were reviewed which have not yet obtained FDA approval including MiroSurge, ViaCath System, SPORT™ Surgical System, SurgiBot, Versius Robotic System, Master and Slave Transluminal Endoscopic Robot, Verb Surgical, Miniature In Vivo Robot, and the Einstein Surgical Robot.ConclusionsThe use and demand for robotic medical and surgical platforms is increasing and new technologies are continually being developed. New technologies are increasingly implemented to improve on the capabilities of previously established systems. Future studies are needed to further evaluate the strengths and weaknesses of each robotic surgical device and platform in the operating suite.

BackgroundRPD (Robotic pancreatoduodenectomy) was first performed by P. C. Giulianotti in 2001 (Arch Surg 138(7):777–784, 2003). Since then, the complexity and lack of technique standardization has slowed down its widespread utilization. RPD has been increasingly adopted worldwide and in few centres is the preferred apporached approach by certain surgeons. Some large retrospective series are available and data seem to indicate that RPD is safe/feasible, and a valid alternative to the classic open Whipple. Our group has recently described a standardized 17 steps approach to RPD (Giulianotti et al. Surg Endosc 32(10): 4329–4336, 2018). Herin, we present an educational step-by-step surgical video with short technical/operative description to visually exemplify the RPD 17 steps technique.MethodsThe current project has been approved by our local Institutional Review Board (IRB). We edited a step-by-step video guidance of our RPD standardized technique. The data/video images were collected from a retrospective analysis of a prospectively collected database (IRB approved). The narration and the images describe hands-on operative “tips and tricks” to facilitate the learning/teaching/evaluation process.ResultsEach of the 17 surgical steps is visually represented and explained to help the in-depth understanding of the relevant surgical anatomy and the specific operative technique.ConclusionsEducational videos descriptions like the one herein presented are a valid learning/teaching tool to implement standardized surgical approaches. Standardization is a crucial component of the learning curve. This approach can create more objective and reproducible data which might be more reliably assessed/compared across institutions and by different surgeons. Promising results are arising from several centers about RPD. However, RPD as gold standard-approach is still a matter of debate. Randomized-controlled studies (RCT) are required to better validate the precise role of RPD.

BackgroundRadical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival.Primary ObjectiveTo investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy.Study HypothesisRobot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes.Trial DesignProspective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden.Major Inclusion/Exclusion CriteriaWomen over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years.Primary EndpointRecurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer.Sample SizeThe clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1−β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients.Estimated Dates for Completing Accrual and Presenting ResultsTrial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter.Trial RegistrationThe trial is registered at ClinicalTrials.gov (NCT03719547).

Sparing the periprostatic neurovascular bundles during robot-assisted radical prostatectomy (RARP) improves postoperative erectile function and early urinary continence recovery. The NeuroSAFE technique, a standardised frozen section analysis, enables accurate real-time detection of positive surgical margins during nerve-sparing, increasing the likelihood of successful nerve preservation. However, the impact of the technique on patient outcomes remains uncertain. We aimed to assess the effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence. NeuroSAFE PROOF was a multicentre, patient-blinded, randomised, controlled phase 3 trial done at five National Health Service hospitals in the UK. Key eligibility criteria were a diagnosis of non-metastatic prostate cancer deemed suitable to undergo RARP, good erectile function (defined as a score of ≥22 on the first 5 items of the International Index of Erectile Function [IIEF]) without medical erectile function assistance, and no previous prostate cancer treatment. No age limits were applied. Participants were randomly assigned (1:1) to standard RARP or NeuroSAFE-guided RARP using block randomisation, stratified by site. Masking of participants to allocation was maintained throughout, but patients were informed of their nerve-sparing status after the operation. Due to the nature of the intervention, operating teams were aware of treatment group. Nerve-sparing was guided by a preoperative plan in the standard RARP group and by intraoperative NeuroSAFE assessment in the NeuroSAFE group. The primary outcome was erectile function at 12 months, assessed using the IIEF-5 score, in the modified intention-to-treat population, which included all randomly assigned participants who had surgery. Secondary endpoints were urinary continence scores at 3 and 6 months, evaluated using the International Consultation on Incontinence Questionnaire (ICIQ), and the erectile function domain of the IIEF (IIEF-6) scores at 12 months. The trial is registered at ClinicalTrials.gov, NCT03317990. Between Jan 6, 2019, and Dec 6, 2022, 407 patients were recruited, of whom 381 had surgery (190 participants in the NeuroSAFE group and 191 participants in the standard RARP group), and were included in the modified intention-to-treat population. Data for the primary outcome (IIEF-5 score at 12 months) were available for 344 participants (173 in the NeuroSAFE group and 171 participants in the standard RARP group). Median follow-up was 12·3 months (IQR 11·8–12·7). At 12 months, the mean IIEF-5 score was 12·7 (SD 8·0) in the NeuroSAFE group versus 9·7 (7·5) in the standard RARP group (adjusted mean difference 3·18 [95% CI 1·62 to 4·75]; p<0·0001). At 3 months, the ICIQ score was significantly lower in the NeuroSAFE group than the standard RARP group (adjusted mean difference –1·41 [95% CI –2·42 to –0·41]; p=0·006). At 6 months, no significant difference in ICIQ score was observed between groups (adjusted mean difference –0·37 [95% CI –1·35 to 0·62]; p=0·46). At 12 months, the mean IIEF-6 score was higher in the NeuroSAFE group than in the standard RARP group (15·3 [SD 9·7] vs 11·5 [SD 9·0]; adjusted mean difference 3·92 [95% CI 2·01 to 5·83]; p<0·0001). Serious adverse events occurred in six (3%) of 190 patients in the NeuroSAFE group, and and in five (3%) of 191 patients in the standard RARP group. All adverse events were postoperative complications; no serious adverse events or deaths were attributed to the study intervention. The use of NeuroSAFE to guide nerve-sparing during RARP improves patient-reported IIEF-5 scores at 12 months and short-term urinary continence. The erectile function benefit is enhanced in patients who would not otherwise have undergone bilateral nerve-sparing by standard practice. National Institute of Healthcare Research, JP Moulton Charitable Foundation, UCLH Charity, St Peters Trust, and Rosetrees Trust.