Feasibility and Safety Study of the Use of a New Robot (Maestro™) for Laparoscopic Surgery.

BACKGROUND: In laparoscopic surgery, telerobotic systems such as Da Vinci™ were developed, among other things, to give back exposure and vision control to the operating surgeon. However, new limitations such as the separation of the operating surgeon from the operating table, cost, and size were unveiled. A new device, Maestro™, appears promising in addressing these limitations. The current work evaluates the feasibility, safety, and surgeon satisfaction with the assistance provided by the Maestro System. METHODS: Non-consecutive patients who were candidates for laparoscopic digestive surgery were enrolled in a descriptive prospective, monocentric study. Case selection was solely based on the availability of the device, but not on the patient's characteristics. Surgery was performed by a leading surgeon with the help of one less experienced surgeon. Feasibility was defined by the maintenance of the initial surgical plan. Safety was assessed by the absence of serious adverse events related to the device and surgeon satisfaction was evaluated by a questionnaire following the intervention. RESULTS: All 50 procedures were completed without conversion in laparotomy and without adjustment of the surgical team. Four complications were recorded during the study; however, none related to the use of the Maestro System. In 92% of the cases, the surgeon was satisfied with the assistance provided by the Maestro System. CONCLUSIONS: In standard elective digestive procedures by laparoscopy, the use of the Maestro System is feasible and safe. It is beneficial to the surgeon and operative room organization by limiting the size of the surgical team.

Sleeve gastrectomy with duodenoileal bipartition using linear magnets: feasibility and safety at 1-year follow-up.

BACKGROUND: Single-anastomosis metabolic/bariatric surgery procedures may lessen the incidence of anastomotic complications. This study aimed to evaluate the feasibility and safety of performing side-to-side duodenoileal (DI) bipartition using magnetic compression anastomosis (MCA). In addition, preliminary efficacy, quality of life (QoL), and distribution of food through the DI bipartition were evaluated. METHODS: Patients with a body mass index (BMI) of ≥35.0 to 50.0 kg/m2 underwent side-to-side DI bipartition with the magnet anastomosis system (MS) with sleeve gastrectomy (SG). By endoscopic positioning, a distal magnet (250 cm proximal to the ileocecal valve) and a proximal magnet (first part of the duodenum) were aligned with laparoscopic assistance to inaugurate MCA. An isotopic study assessed transit through the bipartition. RESULTS: Between March 14, 2022 to June 1, 2022, 10 patients (BMI of 44.2 ± 1.3 kg/m2) underwent side-to-side MS DI. In 9 of 10 patients, an SG was performed concurrently. The median operative time was 161.0 minutes (IQR, 108.0-236.0), and the median hospital stay was 3 days (IQR, 2-40). Paired magnets were expelled at a median of 43 days (IQR, 21-87). There was no device-related serious advanced event within 1 year. All anastomoses were patent with satisfactory diameters after magnet expulsion and at 1 year. Respective BMI, BMI reduction, and total weight loss were 28.9 ± 1.8 kg/m2, 15.2 ± 1.8 kg/m2, and 34.2% ± 4.1%, respectively. Of note, 70.0% of patients reported that they were very satisfied. The isotopic study found a median of 19.0% of the meal transited through the ileal loop. CONCLUSION: Side-to-side MCA DI bipartition with SG in adults with class II to III obesity was feasible, safe, and efficient with good QoL at 1-year follow-up. Moreover, 19% of ingested food passed directly into the ileum.

Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy.

BACKGROUND: Conventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs). OBJECTIVES: The study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]). SETTING: Multicenter: private practices and university hospitals. METHODS: In patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved. CONCLUSIONS: In early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.

First human surgery using a surgical assistance robotics device for laparoscopic cholecystectomies.

BACKGROUND: Over the past 20 years, surgeons involved in soft tissue minimally invasive surgery have experienced the pros and cons of both conventional and tele-robotic laparoscopic approaches. The Maestro System, developed by Moon Surgical (Paris, France) aims to overcome the challenges inherent to both approaches thanks to a new concept that augments the surgeon's performance at the bedside during a laparoscopic procedure. METHODS: The current study aims to present the first human experience with laparoscopic cholecystectomy with the Maestro system on 10 patients. RESULTS: All ten procedures were completed successfully. No significant complications related to the use of the Maestro system werenoted. CONCLUSION: Our preliminary observations appear to support the benefits of the Maestro system in non-emergent laparoscopic cholecystectomies. It goes without saying that further research is necessary to demonstrate the safety of this approach in other procedures.

Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

BACKGROUND: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period. The objective of this clinical trial was to evaluate the preliminary efficacy and safety of the Colovac+. METHODS: This was a prospective, multicenter, pilot study aiming to enroll 15 patients undergoing LAR with Colovac+ placement. After 10 days, a CT scan was performed to evaluate the anastomosis and the Colovac+ was retrieved endoscopically. During the 10-day implantation and 3-month follow-up period, we collected data regarding predefined efficacy and safety endpoints. The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure. RESULTS: A total of 25 patients were included (68% male), of whom 15 were consecutively treated with the Colovac+ and Vacuum Loss Alert System. The Colovac+ was successfully implanted in all 15 patients. No major discomfort was reported during the implantation period. The endoscopic retrieval was performed in 14/15 (93%) patients. The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. A device migration occurred in 2 (13%) patients, but these were not associated with AL or stoma conversion. Overall, Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the PI in 11/15 (73%) patients. CONCLUSIONS: Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the majority (73%) of patients. The improved design reduces the overall migration rate and limits the clinical impact of a migration.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results.

INTRODUCTION: Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. METHODS: In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality. CONCLUSION: In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

Implications of bacteriological study in complicated and uncomplicated acute appendicitis.

Purpose: Bacteriological sample in the presence of intraabdominal free fluid is necessary to adapt the antibiotherapy and to prevent the development of resistance. The aim was to evaluate the differences between uncomplicated (UAA) and complicated acute appendicitis (CAA) in terms of bacterial culture results and antibiotic resistance, and to evaluate the factors linked with CAA. Methods: We performed a single-center, retrospective observational study of all consecutive patients who presented with appendicular peritonitis and underwent emergent surgery in a tertiary referral hospital in Brussels, Belgium, between January 2013 and December 2020. The medical history, parameters at admission, bacterial culture, antibiotic resistance, and postoperative outcomes of 268 patients were analyzed. UAA was considered catarrhal or phlegmonous inflammation of the appendix. CAA was considered gangrenous or perforated appendicitis. Results: Positive microbiological cultures were significantly higher in the CAA group (68.2% vs. 53.4%). The most frequently isolated bacteria in UAA and CAA cultures were Escherichia coli (37.9% and 48.6%). Most observed resistances were against ampicillin (28.9% and 21.7%) and amoxicillin/clavulanic acid (16.4% and 10.5%) in UAA and CAA, respectively. A higher Charlson comorbidity index, an elevated white blood cell count, an open procedure, and the need for drainage were linked to CAA. Culture results, group of bacterial isolation, and most common isolated bacteria were not related to CAA. Conclusion: CAA presented a higher rate of positive cultures with increased identification of gram-negative bacteria. Bacterial culture from the peritoneal liquid does not reveal relevant differences in terms of antibiotic resistance.

Impact of the COVID-19 Pandemic and Lockdown on Gastric Bypass Results at 1-Year Follow-up.

PURPOSE: The COVID-19 pandemic caused a lockdown in many countries, which induced negative dietary habits and sedentary behavior. Studies suggest that weight loss of patients undergoing bariatric surgery was equally affected. The aim was to evaluate the impact of COVID-19 on weight loss, obesity-related comorbidities, and nutritional status at 1-year follow-up after gastric bypass (GB). METHODS: Retrospective observational case-control study of patients undergoing primary GB in a tertiary referral Belgian center. COVID-19 period group was composed by those whose 1-year postoperative period was affected by the COVID-19 pandemic and lockdown: from October 1, 2019, to March 31, 2020. The control group was composed of patients operated from October 1, 2018, to March 31, 2019. Electronic clinical records were reviewed searching: baseline characteristics, weight and comorbidities evolution, and biochemical values. RESULTS: A total of 47 patients in the COVID-19 period group and 66 in the non-COVID-19 period group were analyzed. There were no significant differences in baseline characteristics. A reduced weight loss was observed at 1-year follow-up, in terms of percentage of excess weight loss (%EWL) (82.4% [SD: 21.6] vs. 82.4% [SD: 21.6]; p: 0.043) and body mass index (BMI) (27.8 kg/m2 [IQR: 25.8-30.0] vs. 26.2 kg/m2 [IQR: 24.6-28.6]; p: 0.029) for COVID-19 period group vs. non-COVID-19 period group, respectively. There was a similar reduction of obesity-related comorbidities, without clinically significant differences in the nutritional follow-up. CONCLUSION: The COVID-19 pandemic and lockdown had an impact on weight loss at 1-year follow-up after gastric bypass.

High SARS-CoV-2 Seroprevalence in Healthcare Workers in Bukavu, Eastern Democratic Republic of Congo.

Among 359 healthcare workers (HCW) employed in Panzi General Referral Hospital located in Bukavu in the Democratic Republic of Congo, 148 (41.2%) tested positive for SARS-CoV-2 antibodies. Thirty-three (22.3%) of the 148 personnel with positive serology reported symptoms evoking a prior COVID-19 illness. None of the infected HCWs reported COVID-related hospitalization, and all of them recovered. Our findings indicate high and underestimated circulation of SARS-CoV-2 within the Bukavu area.