Evolution in Laparoscopic Gastrectomy From a Randomized Controlled Trial Through National Clinical Practice.

OBJECTIVE: To examine the influence of the LOGICA RCT (randomized controlled trial) upon the practice and outcomes of laparoscopic gastrectomy within the Netherlands. BACKGROUND: Following RCTs the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. METHODS: Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012-2021), and the LOGICA RCT from 2015 to 2018. Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes before, during, and after the LOGICA RCT. RESULTS: Two hundred eleven patients from the LOGICA RCT (105 open vs 106 laparoscopic) and 4131 patients from the DUCA data set (1884 open vs 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift toward a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction in overall [adjusted odds ratio (aOR):0.62; 95% CI: 0.46-0.82], severe (aOR: 0.64; 95% CI: 0.46-0.90) and cardiac complications (aOR: 0.51; 95% CI: 0.30-0.89) after the LOGICA trial. CONCLUSIONS: The wider benefits of the LOGICA trial included the safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance program in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.

2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial.

BACKGROUND: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. METHODS: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. FINDINGS: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI -1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths. INTERPRETATION: 2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay. FUNDING: The Netherlands Organization for Health Research and Development.

Same-day discharge after appendectomy for acute appendicitis: a systematic review and meta-analysis.

PURPOSE: Patients presenting with acute appendicitis are usually hospitalized for a few days for appendectomy and postoperative recovery. Shortening length of stay may reduce costs and improve patient satisfaction. The purpose of this study was to assess the safety of same-day discharge after appendectomy for acute appendicitis. METHODS: A systematic review was performed according to PRISMA guidelines. A literature search of EMBASE, Ovid MEDLINE, Web of Science, Cochrane Central, and Google Scholar was conducted from inception to April 14, 2020. Two reviewers independently screened the literature and selected studies that addressed discharge on the same calendar day as the appendectomy. Risk of bias was assessed with the ROBINS-I tool. Main outcomes were hospital readmission, complications, and unplanned hospital visits in the postoperative course. A random effects model was used to pool risk ratios for the main outcomes. RESULTS: Of the 1912 articles screened, 17 comparative studies and 8 non-comparative studies met the inclusion criteria. Most only included laparoscopic procedure for uncomplicated appendicitis. Most studies were considered at moderate or serious risk of bias. In meta-analysis, same-day discharge (vs. overnight hospitalization) was not associated with increased rates of readmission, complication, and unplanned hospital visits. Non-comparative studies demonstrated low rates of readmission, complications, and unplanned hospital visits after same-day discharge. CONCLUSION: This study suggests that same-day discharge after laparoscopic appendectomy for uncomplicated appendicitis is safe without an increased risk of readmission, complications, or unplanned hospital visits. Hence, same-day discharge may be further encouraged in selected patients. TRIAL REGISTRATION: PROSPERO registration no. CRD42018115948.

Systematic Review and Meta-Analysis of Postoperative Antibiotics for Patients with a Complex Appendicitis.

Postoperative antibiotics are recommended after appendectomy for complex appendicitis to reduce infectious complications. The duration of this treatment varies considerably between and even within institutions. The aim of this review was to critically appraise studies on duration of antibiotic treatment following appendectomy for complex appendicitis. A systematic literature search according to the PRISMA guidelines was performed. Comparative studies evaluating different durations of postoperative antibiotic therapy. Primary endpoint was intra-abdominal abscess (IAA) after appendectomy. Secondary endpoints were surgical site infection, readmission and length of hospital stay. The quality of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. Pooled event rates were calculated using a random-effects model. Nine studies reporting 2006 patients with complex appendicitis were included. The methodological quality of the included articles was poor. IAA was seen in 138 patients (8,6%). Meta-analysis revealed a statistically significant difference in IAA incidence between antibiotic treatment of ≤5 vs. >5 days (risk ratio (OR) 0.36 [95% CI 0.23-0.57] (p < 0.0001)) but not between ≤3 vs. >3 days (OR 0.81 [95% CI 0.38-1.74] (p = 0.59)). Descriptive statistics were used for secondary endpoints. The duration of postoperative antibiotic treatment is not associated with IAA following appendectomy for complex appendicitis.

The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis.

BACKGROUND: Current perioperative patient care aims to maintain homeostasis by attenuation of the stress response to surgery, as a more vigorous stress response can have detrimental effects on postoperative recovery. This systematic review and meta-analysis aims to assess the effect of perioperative music on the physiological stress response to surgery. METHODS: The Embase, Medline Ovid, Cochrane Central, Web of Science, and Google Scholar databases were searched from inception date until February 5, 2019, using a systematic literature search following the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines for randomized controlled trials investigating the effect of music before, during, and/or after surgery in adult surgical patients on the stress response to surgery. Meta-analysis was performed using a random effects model and pooled standardized mean differences were calculated with 95% confidence intervals. This study was registered in the PROSPERO database (CRD42018097060). RESULTS: The literature search identified 1076 articles. Eighteen studies (1301 patients) were included in the systematic review, of which eight were included in the meta-analysis. Perioperative music attenuated the neuroendocrine cortisol stress response to surgery (pooled standardized mean difference -0.30, [95% confidence interval -0.53 to -0.07], P = 0.01, I2 = 0). CONCLUSIONS: Perioperative music can attenuate the neuroendocrine stress response to surgery.

Lasting symptoms and long-term health-related quality of life after totally minimally invasive, hybrid and open Ivor Lewis esophagectomy.

AIM: Compared to open esophagectomy (OE), both totally minimally invasive (TMIE) and laparoscopy-assisted hybrid minimally invasive (HMIE) reduce postoperative morbidity and improve short-term health-related quality of life (HRQoL). We aimed to compare lasting symptoms and long-term HRQoL in an international population-based setting between patients who underwent Ivor Lewis TMIE, HMIE or OE. METHODS: Patients who were relapse-free at least one year after TMIE, HMIE or OE for esophageal or junctional carcinoma between January 2010 and June 2016 were included. Patients completed the LASER questionnaire to assess lasting symptoms after esophagectomy and the EORTC QLQ-C30 and QLQ-OG25 questionnaires to assess HRQoL. Primary endpoint was chest pain and secondary endpoints were pain from chest scars or abdominal scars, abdominal pain, fatigue and physical functioning. Differences in lasting symptoms and HRQoL were assessed with multivariable logistic and ANCOVA regression, respectively. RESULTS: A total of 362 patients were included (TMIE n = 91, HMIE n = 85, OE n = 186). Median follow-up was 3.9 years (IQR 2.8-5.4). Chest pain was reported less after TMIE compared with HMIE (adjusted OR 0.21, 95% CI 0.05-0.84), but was comparable between TMIE and OE (adjusted OR 0.41, 95% CI 0.12-1.41) and between HMIE and OE (adjusted OR 1.85, 95% CI 0.71-4.81). All secondary endpoints were comparable between TMIE, HMIE and OE. The impact of symptoms on taking medication, return to work, and performance status were comparable between groups. CONCLUSION: Surgical technique seems to have little effect on lasting symptoms and long-term HRQoL after a median of four years after Ivor Lewis esophagectomy.

Intrathoracic vs Cervical Anastomosis After Totally or Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial.

Background: Transthoracic minimally invasive esophagectomy (MIE) is increasingly performed as part of curative multimodality treatment. There appears to be no robust evidence on the preferred location of the anastomosis after transthoracic MIE. Objective: To compare an intrathoracic with a cervical anastomosis in a randomized clinical trial. Design, Setting, and Participants: This open, multicenter randomized clinical superiority trial was performed at 9 Dutch high-volume hospitals. Patients with midesophageal to distal esophageal or gastroesophageal junction cancer planned for curative resection were included. Data collection occurred from April 2016 through February 2020. Intervention: Patients were randomly assigned (1:1) to transthoracic MIE with intrathoracic or cervical anastomosis. Main Outcomes and Measures: The primary end point was anastomotic leakage requiring endoscopic, radiologic, or surgical intervention. Secondary outcomes were overall anastomotic leak rate, other postoperative complications, length of stay, mortality, and quality of life. Results: Two hundred sixty-two patients were randomized, and 245 were eligible for analysis. Anastomotic leakage necessitating reintervention occurred in 15 of 122 patients with intrathoracic anastomosis (12.3%) and in 39 of 123 patients with cervical anastomosis (31.7%; risk difference, -19.4% [95% CI, -29.5% to -9.3%]). Overall anastomotic leak rate was 12.3% in the intrathoracic anastomosis group and 34.1% in the cervical anastomosis group (risk difference, -21.9% [95% CI, -32.1% to -11.6%]). Intensive care unit length of stay, mortality rates, and overall quality of life were comparable between groups, but intrathoracic anastomosis was associated with fewer severe complications (risk difference, -11.3% [-20.4% to -2.2%]), lower incidence of recurrent laryngeal nerve palsy (risk difference, -7.3% [95% CI, -12.1% to -2.5%]), and better quality of life in 3 subdomains (mean differences: dysphagia, -12.2 [95% CI, -19.6 to -4.7]; problems of choking when swallowing, -10.3 [95% CI, -16.4 to 4.2]; trouble with talking, -15.3 [95% CI, -22.9 to -7.7]). Conclusions and Relevance: In this randomized clinical trial, intrathoracic anastomosis resulted in better outcome for patients treated with transthoracic MIE for midesophageal to distal esophageal or gastroesophageal junction cancer. Trial Registration: Trialregister.nl Identifier: NL4183 (NTR4333).

Laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: long-term results of a randomized trial.

BACKGROUND: Postoperative dysphagia in patients after Nissen fundoplication might be related to the technique used for the closure of the esophageal hiatus. METHODS: A total of 102 patients with gastroesophageal reflux were randomized to undergo laparoscopic Nissen fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. RESULTS: Clinical data at 5 years after surgery were available for 96% of patients enrolled in the trial. There was no significant difference between the 2 techniques for symptoms of dysphagia at the 5-year follow-up evaluation, although more patients who underwent posterior hiatal repair underwent further surgery for dysphagia-related symptoms (8 vs 2). Better control of heartburn was achieved in patients in the anterior hiatal repair group. Patients from both groups were equally satisfied with the overall outcome after surgery. CONCLUSIONS: At the 5-year follow-up evaluation, there was no significant difference in dysphagia between anterior closure and posterior hiatal repair.