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.

A multicenter prospective audit to investigate the current management of patients undergoing anti-reflux surgery in the UK: Audit & Review of Anti-Reflux Operations & Workup.

BACKGROUND: There are a variety of surgical and endoscopic interventions available to treat gastroesophageal reflux disease. There is, however, no consensus on which approach is best.The aim of this national audit is to describe the current variation in the UK clinical practice in relation to anti-reflux surgery (ARS) and to report adherence to available clinical guidelines. METHODS: This national audit will be conducted at centers across the UK using the secure online web platform ALEA. The study will comprise two parts: a registration questionnaire and a prospective multicenter audit of ARS. All participating centers will be required to complete the registration questionnaire comprising details regarding pre-, peri-, and post-operative care pathways and whether or not these are standardized within each center. Following this, a 12-month multicenter prospective audit will be undertaken to capture data including patient demographics, predominant symptoms, preoperative investigations, surgery indication, intraoperative details, and postoperative outcomes within the first 90 days.Local teams will retain access to their own data to facilitate local quality improvement. The full dataset will be reported at national and international scientific congresses and will contribute to peer-reviewed publications and national quality improvement initiatives. CONCLUSIONS: This study will identify and explore variation in the processes and outcomes following ARS within the UK using a collaborative cohort methodology. The results generated by this audit will facilitate local and national quality improvement initiatives and generate new possibilities for future research in anti-reflux interventions.

The effect of time between procedures upon the proficiency gain period for minimally invasive esophagectomy.

BACKGROUND: Complex surgical procedures including minimally invasive esophagectomy (MIE) are commonly associated with a period of proficiency gain. We aim to study the effect of reduced procedural interval upon the number of cases required to gain proficiency and adverse patient outcomes during this period from MIE. METHODS: All adult patients undergoing MIE for esophageal cancer in England from 2002 to 2012 were identified from Hospital Episode Statistics database. Outcomes evaluated included conversion rate from MIE to open esophagectomy, 30-day re-intervention, 30-day and 90-day mortality. Regression models investigated relationships between procedural interval and the number of cases and clinical outcomes during proficiency gain period. RESULTS: The MIE dataset comprised of 1696 patents in total, with procedures carried out by 148 surgeons. Thresholds for procedural interval extracted from change-point modeling were found to be 60 days for conversion, 80 days for 30-day re-intervention, 80 days for 30-day mortality and 110 days for 90-day mortality. Procedural interval of MIEs did not influence the number of cases required for proficiency gain. However, reduced MIE procedural interval was associated with significant reductions in conversions (0.16 vs. 0.07; P < 0.001), re-interventions (0.15 vs. 0.09; P < 0.01), 30-day (0.12 vs. 0.05; P < 0.01) and 90-day (0.14 vs. 0.06; P < 0.01) mortality during the period of proficiency gain. CONCLUSIONS: This national study has demonstrated that the introduction of MIE is associated with a period of proficiency gain and adverse patient outcomes. The absolute effect of this period of proficiency gain upon patient morbidity and mortality may be reduced by reduced procedural interval of MIE practice within specialized esophageal cancer centers.

Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis.

Magnetic sphincter augmentation (MSA) has been proposed as a less invasive, more appealing alternative intervention to fundoplication for the treatment of gastroesophageal reflux disease (GERD). The aim of this study was to evaluate clinical outcomes following MSA for GERD control in comparison with laparoscopic fundoplication. A systematic electronic search for articles was performed in Medline, Embase, Web of Science, and Cochrane Library for single-arm cohort studies or comparative studies (with fundoplication) evaluating the use of MSA. A random-effects meta-analysis for postoperative proton pump inhibitor (PPI) use, GERD-health-related quality of life (GERD-HRQOL), gas bloating, ability to belch, dysphagia, and reoperation was performed. The systematic review identified 6 comparative studies of MSA versus fundoplication and 13 single-cohort studies. Following MSA, only 13.2% required postoperative PPI therapy, 7.8% dilatation, 3.3% device removal or reoperation, and esophageal erosion was seen in 0.3%. There was no significant difference between the groups in requirement for postoperative PPI therapy (pooled odds ratio, POR = 1.08; 95%CI 0.40-2.95), GERD-HRQOL score (weighted mean difference, WMD = 0.34; 95%CI -0.70-1.37), dysphagia (POR = 0.94; 95%CI 0.57-1.55), and reoperation (POR = 1.23; 95%CI 0.26-5.8). However, when compared to fundoplication MSA was associated with significantly less gas bloating (POR = 0.34; 95%CI 0.16-0.71) and a greater ability to belch (POR = 12.34; 95%CI 6.43-23.7). In conclusion, magnetic sphincter augmentation achieves good GERD symptomatic control similar to that of fundoplication, with the benefit of less gas bloating. The safety of MSA also appears acceptable with only 3.3% of patients requiring device removal. There is an urgent need for randomized data directly comparing fundoplication with MSA for the treatment of GERD to truly evaluate the efficacy of this treatment approach.

Systematic review comparing radiofrequency ablation and complete endoscopic resection in treating dysplastic Barrett's esophagus: a critical assessment of histologic outcomes and adverse events.

BACKGROUND: With recent advances in endoscopy, endoscopic techniques have surpassed esophagectomy in the treatment of dysplastic Barrett's esophagus (BE). OBJECTIVE: To compare the efficacy and safety of complete EMR and radiofrequency ablation (RFA) in the treatment of dysplastic BE. DESIGN: Systematic review of literature. PATIENTS: Diagnosis of BE with high-grade dysplasia or intramucosal cancer. INTERVENTION: Complete EMR or RFA. MAIN OUTCOME MEASUREMENTS: Complete eradication of dysplasia and intestinal metaplasia at the end of treatment and after >12 months' follow-up. Adverse event rates associated with treatment. RESULTS: A total of 22 studies met the inclusion criteria. Only 1 trial directly compared the 2 techniques; most studies were observational case series. Dysplasia was effectively eradicated at the end of treatment in 95% of patients after complete EMR and 92% after RFA. After a median follow-up of 23 months for complete EMR and 21 months for RFA, eradication of dysplasia was maintained in 95% of patients treated with complete EMR and 94% treated with RFA. Short-term adverse events were seen in 12% of patients treated with complete EMR but in only 2.5% of those treated with RFA. Esophageal strictures were adverse events in 38% of patients treated with complete EMR, compared with 4% of those treated with RFA. Progression to cancer appeared to be rare after treatment, although follow-up was short. LIMITATIONS: Small studies, heterogeneous in design, with variable outcome measures. Also follow-up durations were short, limiting evaluation of long-term durability of both treatments. CONCLUSION: RFA and complete EMR are equally effective in the short-term treatment of dysplastic BE, but adverse event rates are higher with complete EMR.

Laparoscopic versus open colorectal resection in the elderly population.

BACKGROUND: Elderly patients are often regarded as high-risk patients for major abdominal surgery because of a lack of functional reserve and associated medical comorbidities. The aim of this systematic review and pooled analysis was to review the current data published regarding the differences in operative outcomes of laparoscopic and open surgery in the elderly population. METHODS: A systematic literature search of Medline, Embase, Web of Science, and Cochrane databases was performed. Studies that compared outcome following laparoscopic and open colorectal resections in the elderly (≥70) population were included. Primary outcomes were operative death, anastomotic leak, pneumonia, length of hospital stay, and return to bowel function. Secondary outcomes were operative time, intraoperative blood loss, postoperative cardiac morbidity, ileus, and postoperative wound infection. RESULTS: The results of this systematic review and pooled analysis demonstrate the safety and potential benefits of laparoscopic colorectal resection in the elderly population. The latter include reduction in length of hospital stay, intraoperative blood loss, incidence of postoperative pneumonia, time to return of normal bowel function, incidence of postoperative cardiac complications, and wound infections. CONCLUSION: The results of this pooled analysis demonstrate the potential short-term advantages of laparoscopic colorectal resection in the elderly population. Further studies are required to examine the long-term survival following laparoscopic and open colorectal resections in the elderly population.

Misinformation About the Human Gut Microbiome in YouTube Videos: Cross-sectional Study.

BACKGROUND: Social media platforms such as YouTube are integral tools for disseminating information about health and wellness to the public. However, anecdotal reports have cited that the human gut microbiome has been a particular focus of dubious, misleading, and, on occasion, harmful media content. Despite these claims, there have been no published studies investigating this phenomenon within popular social media platforms. OBJECTIVE: The aim of this study is to (1) evaluate the accuracy and reliability of the content in YouTube videos related to the human gut microbiome and (2) investigate the correlation between content engagement metrics and video quality, as defined by validated criteria. METHODS: In this cross-sectional study, videos about the human gut microbiome were searched for on the United Kingdom version of YouTube on September 20, 2021. The 600 most-viewed videos were extracted and screened for relevance. The contents and characteristics of the videos were extracted and independently rated using the DISCERN quality criteria by 2 researchers. RESULTS: Overall, 319 videos accounting for 62,354,628 views were included. Of the 319 videos, 73.4% (n=234) were produced in North America and 78.7% (n=251) were uploaded between 2019 and 2021. A total of 41.1% (131/319) of videos were produced by nonprofit organizations. Of the videos, 16.3% (52/319) included an advertisement for a product or promoted a health-related intervention for financial purposes. Videos by nonmedical education creators had the highest total and preferred viewership. Daily viewership was the highest for videos by internet media sources. The average DISCERN and Health on the Net Foundation Code of Conduct scores were 49.5 (SE 0.68) out of 80 and 5.05 (SE 2.52) out of 8, respectively. DISCERN scores for videos by medical professionals (mean 53.2, SE 0.17) were significantly higher than for videos by independent content creators (mean 39.1, SE 5.58; P<.001). Videos including promotional materials had significantly lower DISCERN scores than videos without any advertisements or product promotion (P<.001). There was no correlation between DISCERN scores and total viewership, daily viewership, or preferred viewership (number of likes). CONCLUSIONS: The overall quality and reliability of information about the human gut microbiome on YouTube is generally poor. Moreover, there was no correlation between the quality of a video and the level of public engagement. The significant disconnect between reliable sources of information and the public suggests that there is an immediate need for cross-sector initiatives to safeguard vulnerable viewers from the potentially harmful effects of misinformation.

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.

Assessment of a Noninvasive Exhaled Breath Test for the Diagnosis of Oesophagogastric Cancer.

Importance: Early esophagogastric cancer (OGC) stage presents with nonspecific symptoms. Objective: The aim of this study was to determine the accuracy of a breath test for the diagnosis of OGC in a multicenter validation study. Design, Setting, and Participants: Patient recruitment for this diagnostic validation study was conducted at 3 London hospital sites, with breath samples returned to a central laboratory for selected ion flow tube mass spectrometry (SIFT-MS) analysis. Based on a 1:1 cancer:control ratio, and maintaining a sensitivity and specificity of 80%, the sample size required was 325 patients. All patients with cancer were on a curative treatment pathway, and patients were recruited consecutively. Among the 335 patients included; 172 were in the control group and 163 had OGC. Interventions: Breath samples were collected using secure 500-mL steel breath bags and analyzed by SIFT-MS. Quality assurance measures included sampling room air, training all researchers in breath sampling, regular instrument calibration, and unambiguous volatile organic compounds (VOCs) identification by gas chromatography mass spectrometry. Main Outcomes and Measures: The risk of cancer was identified based on a previously generated 5-VOCs model and compared with histopathology-proven diagnosis. Results: Patients in the OGC group were older (median [IQR] age 68 [60-75] vs 55 [41-69] years) and had a greater proportion of men (134 [82.2%]) vs women (81 [47.4%]) compared with the control group. Of the 163 patients with OGC, 123 (69%) had tumor stage T3/4, and 106 (65%) had nodal metastasis on clinical staging. The predictive probabilities generated by this 5-VOCs diagnostic model were used to generate a receiver operator characteristic curve, with good diagnostic accuracy, area under the curve of 0.85. This translated to a sensitivity of 80% and specificity of 81% for the diagnosis of OGC. Conclusions and Relevance: This study shows the potential of breath analysis in noninvasive diagnosis of OGC in the clinical setting. The next step is to establish the diagnostic accuracy of the test among the intended population in primary care where the test will be applied.

Research protocol for a diagnostic study of non-invasive exhaled breath analysis for the prediction of oesophago-gastric cancer.

INTRODUCTION: Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from oesophago-gastric cancer remains poor and ranges from 10% to 30%. Early diagnosis is a key strategy to improve survival but early disease stage has non-specific symptoms that are very common while the warning clinical picture often indicates advanced disease. The aim of this research is to validate a breath test to predict oesophago-gastric cancer therefore allowing earlier diagnosis and introduction of treatment. METHODS AND ANALYSIS: The study will include 325 patients and be conducted across four major oesophago-gastric cancer centres in London, UK. This research will utilise selected ion flow-tube mass spectrometry (SIFT-MS) exhaled breath analysis, for comparison of predicted cancer risk based on the previously developed volatile organic compound exhaled breath model, with endoscopic findings and histology biopsies. This will determine the overall diagnostic accuracy for non-invasive breath testing for the diagnosis of oesophago-gastric cancer. ETHICS AND DISSEMINATION: Approval was gained from NRES Committee London, on 16 July 2014 (REC reference 14/LO/1136) for the completion of this study. Different methods of dissemination will be employed including international clinical and patient group presentations, and publication of research outputs in a high-impact clinical journal. This is to ensure that the findings from this research will reach patients, primary care practitioners, scientists, hospital specialists in gastroenterology, oncology and surgery, health policymakers and commissioners as well as NHS regulatory bodies. TRIALS REGISTRATION NUMBER: UKCRN18063; Pre-results.

The impact of pancreatic duct drainage following pancreaticojejunostomy on clinical outcome.

BACKGROUND: The aim of this meta-analysis is to evaluate the effect of stenting the pancreatic duct during pancreaticojejunostomy formation on perioperative outcomes. METHODS: Primary outcome measures were operative mortality and pancreatic fistula. Secondary outcomes were length of hospital stay, reoperation, delayed gastric emptying, estimated blood loss, and length of operation. Internal and external pancreatic stents were grouped together for the purposes of analysis. RESULTS: Six trials were included in this analysis comprising 732 patients. Pancreatic stent placement had no significant effect on operative mortality; however, there was a non-significant trend towards reduced pancreatic fistula. Estimated blood loss, length of operation, and length of hospital stay were significantly increased in association with pancreatic stent placement. There were no significant effects on reoperation or delayed gastric emptying. CONCLUSION: This analysis demonstrates a trend towards reduced pancreatic fistula with the use of pancreatic stents in pancreaticojejunostomy. However, there were insufficient data to confidently reject the null hypothesis that stenting has no beneficial effect. Further research is required to identify whether in certain subgroups, such as those with soft pancreatic texture and a non-dilated duct, stents may have a more important role in reducing fistula formation.

Hand-sewn versus stapled oesophago-gastric anastomosis: systematic review and meta-analysis.

OBJECTIVE: In this meta-analysis, data from relevant randomised controlled trials has been pooled together to gain a consensus in the comparison of outcome following hand-sewn versus stapled oesophago-gastric (OG) anastomoses. METHODS: Medline, Embase, Cochrane, trial registries, conference proceedings and reference lists were searched for randomised controlled trials comparing hand-sewn and stapled OG anastomoses. Primary outcome measures were 30-day mortality, anastomotic leakage and stricture. Secondary outcomes were operative time, cardiac complications and pulmonary complications. RESULTS: Nine randomised trials were included in this meta-analysis. There was no significant difference between the groups for 30-day mortality (pooled odds ratio = 1.71; 95% CI = 0.822 to 3.56; P = 0.15) and anastomotic leakage (pooled odds ratio = 1.06; 95% CI = 0.62 to 1.80; P = 0.83). There was a significantly increased rate of anastomotic stricture associated with stapled OG anastomosis (pooled odds ratio = 1.76; 95% CI = 1.09 to 2.86; P = 0.02). DISCUSSION: Meta-analysis of randomised controlled trials comparing hand-sewn with stapled OG anastomosis demonstrates that a stapled anastomosis is associated with a shorter operative time but with an increased rate of post-operative anastomotic stricture.

Laparoscopic versus open appendicectomy in obese patients.

BACKGROUND: Although there appears to be no outright benefit of laparoscopic versus open surgery for acute appendicitis in the general population, it has been suggested that in obese patients a laparoscopic approach may offer more conclusive gains. The aim of this pooled analysis of comparative studies was to evaluate clinical outcome following laparoscopic and open appendicectomy in the obese population. METHODS: A systematic literature search of MEDLINE, Embase, Web of Science and the Cochrane Library databases was performed. Primary outcomes were length of operation (min) and length of hospital stay (days). Secondary outcomes were presence of post-operative complications, wound and intra-abdominal complications. Weighted mean differences were calculated to assess the size of the effect of laparoscopic appendicectomy on continuous variables and Pooled odds ratio were calculated for discrete variables. RESULTS: 2309 appendicectomies were included in this analysis, 1122 laparoscopic and 1187 open appendicectomies. Analysis of primary outcome measures revealed a shorter length of post-operative stay associated with laparoscopic appendicectomy (weighted mean difference = -1.26; 95% confidence interval = -2.36 to -0.16; p = 0.02). There was no significant difference between the groups for length of operation, post-operative complications, intra-abdominal or wound complications. CONCLUSION: The results of this pooled analysis indicate that laparoscopic appendicectomy may be beneficial in the obese population with a shorter length of hospital stay, and a similar incidence of post-operative complications.