The hinotori™ surgical robotic system, by Medicaroid (Medicaroid Corporation, Kobe, Japan), is a new robotic system for minimally invasive surgery. We aimed at evaluating its usability and ...accessibility in a preclinical setting. This was a preclinical feasibility study. Two groups of surgeons, one with three experienced robotic surgeons (group 1) and one with three robotic-surgery naive participants (group 2), performed the following tasks using the hinotori™ system in a simulated preclinical setting: console setup, docking, instrument exchange, undocking, and suturing. Each participant repeated each task three times. The time required for performing each repetition and the count of failed repetitions were the primary outcomes of the study. The subjectively perceived workload in performing the tasks, as measured by the NASA-TLX score, was the secondary outcome. The improvement of participants within the three repetitions as well as a comparison between the performances of group 1 and 2 were evaluated. The time required to perform each task decreased with repetitions for both groups, so did the subjective workload score. The time measures required to perform the tasks and the mental effort scores were comparable between the two groups for the console setup, docking, instrument exchange, and undocking tasks. The NASA-TLX score was also comparable between the two groups for the console setup and the emergency undocking tasks and decreased significantly within all tasks after the third repetition. The incidence of failed repetitions was higher in group 2 for the suturing task, however the difference was not statistically significant. The results confirmed the usability of the hinotori™ system in a preclinical setting for both highly trained surgeons and nonexperienced operators and its accessibility for both long-time users of other systems and first-time users.
Background
The magnetic sphincter augmentation (MSA) procedure is an effective treatment for gastroesophageal reflux disease (GERD). Adverse events requiring MSA device removal are rare, but the true ...prevalence and incidence may be underestimated.
Methods
Retrospective study on a prospectively collected database. Patients who underwent MSA procedure between March 2007 and September 2021 in two tertiary-care referral centers for esophageal surgery were included. The trend of MSA explant, the changes in the sizing technique and crura repair over the years, the technique of explant, and the clinical outcomes of the revisional procedure were reviewed.
Results
Out of 397 consecutive patients, 50 (12.4%) underwent MSA removal, with a median time to explant of 39.5 IQR = 53.7 months. Main symptoms leading to removal were dysphagia (43.2%), heartburn (25%), and epigastric pain (13.6%). Erosion occurred in 2.5% of patients. Smaller (12- and 13-bead) devices were the ones most frequently explanted. The majority of the explants were performed laparoscopically with endoscopic assistance. There was no perioperative morbidity, and the median length of stay was 2.8 ± 1.4 days. After 2014, changes in sizing technique and crura repair resulted in a decreased incidence of explants from 23% to 5% (
p
< 0.0001). Multivariate analysis confirmed the protective role of added bead units HR 0.06 (95% CI = 0.001–0.220);
p
< 0.000.
Conclusion
Oversizing and full mediastinal dissection with posterior hiatoplasty may improve the outcomes of the MSA procedure and possibly reduce removal rates.
In 2016, biosimilar enoxaparin (Inhixa
®
, Techdow) was introduced in European markets with the same indications as branded enoxaparin (Clexane
®
, Sanofi). Its use is constantly increasing in ...clinical practice, however, little information from post-marketing clinical trials is available on its safety and effectiveness. We conducted an observational, retrospective study to assess the safety and effectiveness of Inhixa in preventing venous thromboembolism (VTE) in medically ill patients and in patients undergoing major abdominal surgery. We then compared our results with the incidence of symptomatic VTE and bleeding events during treatment with Clexane by pooling the results of clinical studies carried out in the same settings. We enrolled 381 patients, 189 admitted to a Medical Department and 192 to a Surgical Department from two single institutions. The incidence of major bleeding events was 1.8% globally (95% IC 0.7–3.8), 1.6% in medical patients (95% IC 0.3–4.6) and 2.1% in surgical patients (95% IC 0.6–5.3). VTE rate was 0.5% in the whole population (95% IC 0.1–1.9) and 0.5% (95% IC 0.01–2.9) in each group, respectively. The pooled estimate of the incidence of major bleeding with Clexane was 0.5% (IC 95%: 0.2–1.1) in medical patients and 2.6% (IC 95% 1.3–5.1) in surgical patients. The incidence of thrombotic events was 0.6% (IC 95%: 0.2–1.8) and 0.7% (CI95% 0.3–1.6), respectively. The incidence of bleeding and thrombosis in medical and surgical patients receiving Inhixa was low suggesting biosimilar enoxaparin is a valid alternative to branded enoxaparin.
Abstract
Laparoscopic fundoplication is the current surgical gold standard for the treatment of refractory gastroesophageal reflux disease (GERD). Magnetic sphincter augmentation (MSA) is a less ...invasive, standardized, and reversible option to restore competency of the lower esophageal sphincter. A comparative cohort study was conducted at a tertiary-care referral center on patients with typical GERD symptoms treated with systematic crural repair combined with Toupet fundoplication or MSA. Primary study outcome was decrease of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score. Between January 2014 and December 2021, a total of 199 patients (60.3% female, median Q1–Q3 age: 51.0 40.0–61.0) underwent MSA (n = 130) or Toupet fundoplication (n = 69). Operative time and hospital stay were significantly shorter in MSA patients (P < 0.0001). At a median follow-up of 12.0 12.0–24.0 months, there was a statistically significant decrease of GERD-HRQL score in both patient groups (P = 0.001). The mean delta values did not significantly differ between groups (P = 0.7373). The incidence of severe gas bloating symptoms was similar in the two groups (P = 0.7604), but the rate of persistent postoperative dysphagia was greater in MSA patients (P = 0.0009). Six (8.7%) patients in the Toupet group had recurrent hiatal hernia requiring revisional surgery in one (1.4%). In the MSA group, eight (7.9%) patients necessitated through-the-scope balloon dilation for relief of dysphagia, and six patients had the device removed (4.6%) because of persistent dysphagia (n = 3), device disconnection (n = 1), persistent reflux (n = 1) or need of magnetic resonance (n = 1). Toupet and MSA procedures provide similar clinical outcomes, but MSA is associated with a greater risk of reoperation. Randomized clinical trials comparing fundoplication and MSA are eagerly awaited.
Summary
Background
The burden of gastroesophageal reflux disease (GERD) is high, with up to 30% of the Western population reporting reflux-related symptoms with or without hiatal hernia. Magnetic ...sphincter augmentation (MSA) is a standardized laparoscopic procedure for patients who are dissatisfied with medical therapy and for those with early-stage disease who would not usually be considered ideal candidates for fundoplication. The MSA device is manufactured in different sizes and is designed to augment the physiologic barrier to reflux by magnetic force.
Methods
An extensive scoping review was performed to provide a map of current evidence with respect to MSA, to identify gaps in knowledge, and to make recommendations for future research. All the authors contributed to the literature search in PubMed and Web of Science and contributed to summarizing the evidence.
Results
Magnetic sphincter augmentation, especially in combination with crural repair, is effective in reducing GERD symptoms, proton pump inhibitor use, and esophageal acid exposure, and in improving patients’ quality of life. Safety issues such as device erosion or migration have been rare and not associated with mortality. The MSA device can be removed laparoscopically if necessary, thereby preserving the option of fundoplication or other therapies in the future. Contraindication to scanning in high-power Tesla magnetic resonance systems remains a potential limitation of the MSA procedure. High-resolution manometry and functional lumen imaging probes appear to be promising tools to predict procedural outcomes by improving reflux control and reducing the incidence of dysphagia.
Conclusion
A consensus on acquisition and interpretation of high-resolution manometry and impedance planimetry data is needed to gain better understanding of physiology, to improve patient selection, and to pave the way for a personalized surgical approach in antireflux surgery.
Minimally invasive Ivor-Lewis Esophagectomy (MIE) is widely accepted as a surgical treatment of resectable esophageal cancer. Aim of this paper is to describe the surgical details of our standardized ...MIE technique and its safety. We also evaluate the esophageal mobilization in semiprone compared to the left lateral position. A retrospective analysis of 141 consecutive patients who underwent Ivor-Lewis esophagectomy for cancer, from February 2016 to September 2021, was conducted. All the procedures were performed by totally thoraco-laparoscopic with an intrathoracic end-to-side circular stapled anastomosis. Thoracic phase was performed in left lateral position (LLP-group, n=47) followed by a semiprone position (SP-group, n=94). The intraoperative and postoperative outcomes were prospectively collected and analyzed. The procedure was completed without intraoperative complication in 94.68% of cases in SP-group and in 93.62% of cases in LLP-group (P=0.99). The total operative time and thoracic operative time were significantly shorter in SP-group (P=0.0096; P=0.009). No statistically significant differences were detected in postoperative outcomes between the groups, except for anastomotic strictures (higher in LLP-group, P=0.02) and intensive care unit stay (longer in LLP-group, P=00.1). No reoperation was needed in any cases. Surgical radicality was comparable; the median of harvested lymph nodes was significantly higher in SP-group (P<0.0001). The present semiprone technique of thoraco-laparoscopic Ivor-Lewis esophagectomy is safe and feasible but may also provide some advantages in terms of lymph nodes harvested and total operation time.
Robotic-assisted minimally invasive esophagectomy (RAMIE) represents an established approach for the treatment of esophageal cancer. Aim of this study is to evaluate the feasibility and safety of our ...technique for performing the intrathoracic anastomosis during RAMIE.All the procedures were performed by the same surgeon using the same technique for performing the intrathoracic anastomosis. Intraoperative and postoperative outcomes were recorded. Postoperative complications were classified according to the Esophagectomy Complications Consensus Group (ECCG); the primary outcome was the evaluation of the feasibility and safety of our technique. From 2016 to 2021, 204 patients underwent Ivor Lewis RAMIE at our Center. Two patients (0.9%) were converted during the thoracic phase. The anastomosis was completed in all the other patients forming complete anastomotic rings. The median duration for the robotic-assisted thoracoscopic phase was 224 minutes. Twenty-two of the RAMIE-Ivor Lewis patients had an anastomotic leakage (10.3%). The overall 90-day postoperative mortality was 1.9%. The procedure resulted to be feasible and safe in our cohort of patients.
Esophageal submucosal tumors (SMTs) are rare heterogenous clinical entities. The surgical resection can be performed in different surgical approaches. However, the robotic surgical strategy is poorly ...documented in the treatment of SMTs. We present our series of operated esophageal SMTs approached via robotic-assisted surgery. Six patients with symptomatic esophageal submucosal tumors underwent robotic surgery within a 3-year period. The performed procedures were robotic-assisted enucleation, robotic esophagectomy (RAMIE) and reverse hybrid robotic esophagectomy. Patients’ clinical data, intra/postoperative outcomes, and histopathological features were retrieved from the institution’s prospective database. Five of six patients were scheduled for upfront surgery: four underwent robotic enucleation (three leiomyoma and one suspected GIST) and one underwent reverse hybrid robotic esophagectomy (suspected GIST). One patient, diagnosed with GIST, was treated with neoadjuvant Imatinib therapy, before undergoing a RAMIE. No major intra-operative complications were recorded. Median length of stay was 7 days (6–50), with a longer post-operative course in patients who underwent esophagectomy. Clavien–Dindo > 3a complications occurred in two patients, aspiration pneumonia and delayed gastric emptying. The final histopathological and immuno-histochemical diagnosis were leiomyoma, well-differentiated GIST, low-grade fibromyxoid sarcoma and Schwannoma. Robotic-assisted surgery seems to be a promising option for surgical treatment strategies of benign or borderline esophageal submucosal tumors.
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