Safety profile of magnetic sphincter augmentation for gastroesophageal reflux disease.

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.

Comparative outcomes of Toupet fundoplication and magnetic sphincter augmentation.

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.

Semiprone thoracoscopic approach during totally minimally invasive Ivor-Lewis esophagectomy seems to be beneficial.

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.

Burden of Colovesical Fistula and Changing Treatment Pathways: A Systematic Literature Review.

PURPOSE: Colovesical fistula (CVF) is a rare complication of sigmoid diverticulitis causing significant morbidity and quality of life impairment. Aim of this study was to analyze contemporary literature data to appraise the current standard of care and changes of treatment algorithms over time. MATERIALS AND METHODS: A systematic review of the literature on surgical management of CVF was conducted through PUBMED, EMBASE, and COCHRANE databases, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement guidelines. RESULTS: Fourteen papers published between 2014 and 2020 and including 1061 patients were analyzed. One-stage colonic resection with primary anastomosis, with or without loop ileostomy, was the most common surgical procedure. A laparoscopic or robotic approach was attempted in 39.5% of patients, and conversion rate to open surgery was 7.8%. Clavien-Dindo grade ≥3 complication rate, 30-day mortality, and recurrence rate were 7.4%, 1.5%, and 0.5%, respectively. CONCLUSIONS: Minimally invasive sigmoidectomy with primary anastomosis is safe and should be the first-choice approach for CVF. Bladder repair is not necessary after a negative intraoperative leak test. A standardized perioperative care can improve clinical outcomes and reduce the length of hospital stay and the duration of Foley catheterization.

Robotic-assisted surgery for esophageal submucosal tumors: a single-center case series.

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.

End to side circular stapled anastomosis during robotic-assisted Ivor Lewis minimally invasive esophagectomy (RAMIE).

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.

[Complete response after neoadjuvant therapy for gastric cancer: implications for surgery]. / Komplette Response nach neoadjuvanter Therapie beim Magenkarzinom: Implikationen für die Chirurgie.

BACKGROUND: Perioperative or neoadjuvant therapy is the mainstay of treatment for locally advanced gastric cancer in Europe; however, data regarding possible modifications in the surgical strategy depending on the response to preoperative treatment are lacking. METHODS: This review was carried out based on a search of the relevant contemporary literature regarding neoadjuvant or perioperative treatment for gastric adenocarcinoma and the implications of tumor response for the subsequent surgical treatment. RESULTS: The most recent randomized trials showed a survival benefit after perioperative or neoadjuvant treatment for gastric cancer. Due to the variable response to the preoperatively administered part of the therapy, including complete response, it appears reasonable to develop an individualized surgical approach; however, scientific results supporting this approach are limited due to the variable quality of the surgical resection provided in these studies and the limited rate of complete response to preoperative treatment. Moreover, the reliability of clinical restaging after preoperative treatment is also limited. On the other hand, there is currently evidence that supports a re-evaluation of the necessary resection margins for partial gastrectomy in advanced gastric cancer with the help of intraoperative frozen sections and new reconstruction methods. CONCLUSION: The current evidence does not support the implementation of a complete organ-sparing strategy with active follow-up surveillance for gastric cancer.; however, stomach-preserving partial gastrectomy techniques could be applied for advanced disease more often in the future.

Safety and effectiveness of biosimilar enoxaparin (Inhixa) for the prevention of thromboembolism in medical and surgical inpatients.

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.

Retroperitoneoscopic Drainage of Psoas Abscess: A Systematic Review.

BACKGROUND: Psoas abscess is a relatively rare clinical condition that can occur worldwide, is difficult to diagnose, and has a severe clinical course. Conventional treatment ranges from antibiotic therapy alone to computed tomography (CT)-guided and/or open surgical drainage. Retroperitoneoscopic drainage represents a minimally invasive and potentially definitive therapeutic option. MATERIALS AND METHODS: A systematic review of the literature on minimally invasive extraperitoneal access for drainage of psoas abscess was conducted through PUBMED, EMBASE, and COCHRANE databases, according to the PRISMA statement guidelines. We considered only studies in English and with a full text. The quality of all selected articles was assessed for the risk of methodological bias. Additional literature sources were used to put into context the indications and limits of retroperitoneoscopic drainage. RESULTS: Seven papers published between 2004 and 2020, including a total of 56 patients, met the eligibility criteria and were included in the qualitative analysis. Causative agents of psoas abscess included Mycobacterium tuberculosis, Klebsiella pneumoniae, Enterobacter aerogenes, Staphylococcus aureus, and Streptococcus spp. Tuberculous abscess was more common than pyogenic abscess (92.8% vs. 7.2%). Main clinical findings were back pain (76.8%) and fever (53.6%). All patients were preoperatively evaluated by CT or magnetic resonance imaging. Only 4 patients (7.1%) had previously undergone CT-guided percutaneous drainage. Retroperitoneoscopic drainage was combined with antibiotic therapy in all cases. No Clavien-Dindo grade >3 complications occurred, and there was no 30-day postoperative mortality. The recurrence rate was 1.8% at a mean follow-up of 21 months. CONCLUSION: Retroperitoneoscopic surgical drainage is a safe and effective approach for the treatment of psoas abscess.

Retroperitoneoscopic drainage of cryptogenic psoas abscess.

Psoas abscess is a rare and occasionally life-threatening condition. In the past, the major cause of psoas abscess was a descending infection originating from spine tuberculosis (Pott's disease). Subsequently, secondary infection from spondylodiscitis or Crohn's disease has become the prevalent aetiology. Conventional treatment ranges from antibiotic therapy alone to CT-guided and/or surgical drainage. We present the case of a 67-year-old man with a complex history, including pneumonia, sepsis and previous muscle-skeletal trauma. The patient subsequently developed a psoas abscess that was successfully treated with a minimally invasive retroperitoneoscopic approach and antibiotics. Blood cultures and pus yielded Gram-positive Streptococcus sp, and transesophageal echocardiography identified endocarditis as a possible source of sepsis. Postoperative clinical course was complicated by recurrent sepsis that required a change of antibiotic therapy. The patient was eventually discharged to rehabilitation care without further complications. The retroperitoneoscopic approach is safe and effective for the treatment of cryptogenic psoas abscess.