Minimally Invasive Therapy & Allied Technologies最新文献

Background: The purpose of this study was to evaluate the feasibility, safety, and efficacy of robotic single-port hysterectomy (R-SPH) with the da Vinci SP in low-risk endometrial cancer.

Methods: Patients with clinically confirmed endometrioid endometrial cancer, FIGO stages IA-IB, were enrolled for R-SPH. All surgical procedures were performed through a single 2.5 cm umbilical incision. An Intuitive Access Port of small size was placed into the incision, and pneumoperitoneum was established. Robotic instruments were inserted as described below through the Intuitive Access Port, which has four different channel ports: in the superior channel, a three-dimensional 8.5 mm optics; in channel 1, Cadiere Forceps; in channel 2, a Maryland Bipolar; and in channel 3, monopolar scissors.

Results: From June 24 to November 13, 2024, a total of 25 patients were included in the study. The median age was 61 years, and median BMI was 25.9 kg/m². The median docking time, console time, and total operative time were 10, 65, and 115 min, respectively. The median blood loss was 67.0 mL, and the median hemoglobin drop was 1.2 g/dL.

Conclusions: R-SPH seems safe and feasible in endometrial cancer. The true benefit of the technique should be sought in larger comparative studies. ClinicalTrials.gov Protocol Record: NCT06681831.

Background: To validate whether the SATA-LRS, a novel reusable articulating laparoscopic instrument, fits surgical practice, a pre-clinical study was performed.

Methods: Thirteen medical doctors used the instrument in a laparoscopic endoscopic inguinal hernia repair (TEP)-like task inside a cadaver. A set of sensors on the instrument handle detected motion and articulation of the instrument tip. Data from the sensors and video recordings were used to assess the amount and type of movement of the instrument and the time spent on tasks. questionnaire was used to gain insight into the participants' perception of the contextual factors.

Results: There was no difference between task time and instrument tip velocities when using articulation (or not) and all participants used articulation at least half of the task time. Instrument-handle movement, indicating the user's hand and arm movement, was significantly reduced when using articulation. The questionnaire indicated strong acceptance of the instrument and the experimental setup, and a desire to use the instrument in surgery by most participants.

Conclusions: The added articulation feature of the SATA-LRS instrument was deemed beneficial by the participants, showed no increased handling complexity or time spent on the task and was used frequently when enabled, indicating intuitiveness.

Background: This pilot study investigates the adaptability of the articulating instrument (ArtiSential) among surgeons with different levels of experience in conventional laparoscopic surgery.

Methods: From June to November 2023, 18 laparoscopic surgeons participated in peg transfer and suture training using ArtiSential instruments. Participants were categorized into novice, intermediate, and expert groups. Peg transfer was repeated three times, comparing dominant and non-dominant hand. Suture training was conducted at four directional positions (1, 12, 3, and 5 o'clock) and analyzed across three trials.

Results: In terms of peg transfer timing analysis, there are significant differences between the three groups in the first (p < 0.001) and second trials (p = 0.011). However, in the third trial, the gap between the three groups decreased. In all three groups, the suture times at 3 o'clock and 5 o'clock were consistently lower compared to the 1 o'clock and 12 o'clock directions. As the trials progressed, the time decreased for suturing in all directions. Among them, the novice group had reduced suture times at 3 o'clock and 5 o'clock direction.

Conclusions: The ArtiSential instrument is adaptable even for novices. Its articulating features facilitate suturing in traditionally difficult directions (3 o'clock and 5 o'clock) for right-handed users.

Background: The purpose of this study was to illustrate the technique of our full retroperitoneoscopic radical nephroureterectomy (frRNU) involving an intracorporeal, extravesical bladder cuff excision (BCE) and assess its safety and early oncological outcomes.

Methods: Between June 2020 and November 2023, 27 patients underwent frRNU for upper tract urothelial carcinoma. Surgical and oncological outcomes were assessed.

Results: Two (7%) patients were converted to open distal ureterectomy due to extensive fibrosis of the iliac ureter. Lymph node dissection (LND) was performed in 85% of procedures. Median operative time and blood losses were 230 (IQR: 188, 255) minutes and 125 (IQR: 100, 150) mL, respectively. Complication rate was 33%, with only two (7%) Clavien Dindo ≥ 3 complications and two (7%) patients experienced urinary fistula. Catheter was removed after six (IQR: 5, 7) days. All patients had negative surgical margins and three (11%) were pN+, with 6.5 (IQR: 3, 14) nodes removed. At a median follow-up of 11 (IQR: 3, 25) months, four (15%) patients had bladder recurrence, while no retroperitoneal recurrence occurred.

Conclusions: Our frRNU is feasible and safe, allowing for appropriate BCE and LND. Surgical outcomes are optimal, complication rate acceptable and short-term oncological outcomes promising.

Background: Laser lithotripsy is a minimally invasive procedure performed by a urologist using a ureteroscope, a device composed of a flexible laser fiber and a camera. The camera is used to physically view and manually target the stone ablated by the laser. The procedure involves the risk of unintentional trauma caused by the laser when the stones are out of target due to their retro-pulsive movement.

Methods: To minimize clinical complications, we propose a Level I/II autonomous system in robotic lithotripsy. The system consists of a robotic catheter and an integrated U-Net segmentation method. The system aims to automatically target the stones during lithotripsy and guide ureteroscope navigation autonomously.

Results: The proposed system is designed and validated using a phantom specifically manufactured to investigate the feasibility of autonomous stone ablation. An overall target accuracy of 99.97% (leave-one-out: 99.971 min, 99.975 max) was reported.

Conclusions: We successfully implemented a stone targeting method and integrated it with our robotic system to evaluate the level of success in autonomously targeting the stones. The results, indicate that autonomy in robot assisted lithotripsy is feasible.

Background: Functional end-to-end anastomosis (FEEA) and the overlap methods for reconstruction after totally laparoscopic total gastrectomy (TLTG) pose technical challenges. We developed a modified T-shaped FEEA to facilitate the procedure. This study aimed to evaluate the short- and long-term outcomes of the modified T-shaped FEEA compared to the overlap method following TLTG for gastric cancer (GC).

Method: This cohort study enrolled 114 patients with middle- or upper-third GC who underwent TLTG with linear stapler for reconstruction between August 2015 and October 2020. Outcomes analyzed included operative characteristics, postoperative complications, one-year nutritional status, and long-term survival. Propensity score-matched (PSM) was applied to adjust for baseline differences between groups.

Results: After PSM, 27 patients were included in each group. No significant differences were found between the two groups in terms of early surgical outcomes, including operating time, time of first flatus, overall morbidities and mortality, and postoperative hospital stays. However, the modified T-shaped FEEA group had a significantly shorter anastomosis time (37.2 vs. 50.7 min, p = 0.005). Changes in body weight, hemoglobin, and albumin levels one-year postoperatively were comparable. Similarly, there was no significant difference in five-year overall survival and disease-free survival between the two groups (60% vs. 53% and 49% vs. 40%, respectively).

Conclusions: The modified T-shaped FEEA method offers a viable alternative to the overlap method for reconstruction after TLTG for GC, with shorter anastomosis time and comparable surgical and long-term outcomes.

Background: Contemporary methods for detecting cancer in significant rectal neoplasia before transanal excision are suboptimal. Fluorescence angiography (FA) coupled with artificial intelligence (AI) classification methods may add value. This regulated clinical trial stage of the CLASSICA Project will validate the concept using software as medical device.

Methods/design: This multi-centre prospective study will validate a real-time AI-driven FA method for the digital detection of rectal cancer in-situ and endoscopic biopsy guidance. Traditional endoscopic biopsies and excision specimen pathology are the comparative standard aiming to enrol up to 127 patients from seven surgical cancer centres across five countries with trans-European data sharing protocols balancing General Data Protection Regulation (GDPR), Good Clinical Practice (GCP) and adherence to FAIR principles.

Discussion: This CLASSICA phase builds on prior prospective multi-centre and multidisciplinary collaboration that has already recruited 130 patients demonstrating patient and physician capability for the fundamental technique and enlarging the prior training dataset (n = 200 FA videos). Alongside the development of a secure, online data-sharing platform and clinical-grade medical device software, trial protocols have begun institutional approval processes aiming to determine accuracy and further optimisation.

Trial details and registration: The CLASSICA Project is registered with ClinicalTrials.gov [NCT05793554] and is funded by Horizon Europe [Project No.101057321]. CLASSICAPROJECT.EU.

Background: An ideal adhesive for gastrointestinal use should be flexible, transparent, biodegradable, and resistant to gastric acid and pancreatic enzymes. Traditional gelatin-based gummy bears are flexible, transparent, and biodegradable but dissolve quickly. The novel polyurethane-based adhesive VIVO 120^™ mimics these properties but resists digestive fluids, making it a promising candidate for gastric and pancreatic applications.

Methods: The polyurethane-based adhesive VIVO 120^™ was evaluated over 21 days under various conditions (water, acetic acid, pancreatic enzyme solution) at room temperature. Gelatin, fat and fibrin glue served as controls. The adhesive's behavior was monitored using computed tomography (CT) to track physical changes, and macroscopic evaluations were performed at the conclusion of the study to assess any alterations in structure and weight. Additionally, the handling of VIVO 120^™ for sealing pancreatic anastomoses was tested in porcine cadavers.

Results: Over the 21-day period, the VIVO 120^™ samples exhibited significant swelling, with a length increase of 32% in pancreatic enzyme solutions and 51-58% in water and acetic acid. Weight gain reached 179% in water, 226% in acetic acid, and 135% in pancreatic enzymes. Despite these changes, the adhesive maintained its structural integrity. CT imaging showed that the majority of swelling occurred within the first 24 h. No leaching of components into the surrounding fluids was detected. In porcine cadavers, the adhesive demonstrated good handling properties and remained transparent after curing, allowing visual inspection of the anastomosis. Burst pressure tests demonstrated sealing effectiveness up to 40 mmHg. Minor intraluminal detachment was observed under pressure.

Conclusions: VIVO 120^™ demonstrates strong resistance to acidic and enzymatic degradation while offering flexibility, transparency, and good usability. This suggests its potential as a tissue adhesive in gastric and pancreatic surgery. However, its tendency for swelling must be considered, particularly in applications involving confined spaces.

Background: Whilst endoscopic retrograde cholangiopancreatography (ERCP) remains the main line of treatment for choledocholithiasis, laparoscopic common bile duct exploration (LCBDE) offers a single-stage procedure and reduced hospital stay, cost and pressure on ERCP. However, LCBDE is a demanding technique that requires training in order to master, which could be achieved through simulation. The aim of this study was to highlight the suitability of currently available LCBDE simulators for surgical training and evaluate their practicality.

Methods: Database search included Embase and Medline as well as grey literature for LCBDE simulation and training.

Results: Nine dedicated simulators were identified to train on LCBDE. Five simulators were validated, of which only three are commercially available and only one model could train on laparoscopic ultrasound using augmented reality.

Conclusions: Most identified LCBDE simulators are meeting basic criteria to train on the procedure steps. Synthetic models have been shown to improve training and operative performance in addition to shortening learning curves, many at low cost, especially when used within a constructed surgical curriculum program. However, more investment in development and implementation is required to meet the growing need, including training on laparoscopic ultrasound. Only one primitive virtual reality-based simulator was identified and did not meet the criteria for training.

Background: Apical pelvic organ prolapse (POP) significantly impacts quality of life. The vaginal natural orifice transluminal endoscopic surgery lateral suspension (vNOTES LS) combines the benefits of vNOTES and mesh-based suspension. This study compares clinical outcomes of vNOTES LS and laparoscopic lateral suspension (LLS) in patients with ≥ Stage 3 apical POP.

Methods: In this retrospective cohort study, 80 patients with ≥ Stage 3 apical and/or anterior wall defects underwent hysterectomy with vNOTES LS (n = 40) or LLS (n = 40) between January 2022 and January 2024. Perioperative parameters, postoperative outcomes, and POP-Q measurements (Ba and C) were analyzed.

Results: Preoperative characteristics, including BMI and prolapse stage, were comparable. Postoperative POP-Q measurements (Ba and C) significantly improved in the vNOTES LS group at day 1, month 6, and year 1 (p < 0.05). Operative time and hematocrit changes were similar (p > 0.05). Hospital stay was shorter with vNOTES LS (1.05 ± 0.22 vs. 2.2 ± 0.75 days, p < 0.05), and fewer complications were noted. No urinary injury, mesh erosion, or recurrence occurred in the vNOTES LS group.

Conclusions: vNOTES LS demonstrated comparable success to LLS with shorter hospital stays and fewer complications. Its minimally invasive nature highlights its potential as a promising alternative for selected patients.