BACKGROUND: A body of evidence supports a link between metabolic bariatric surgery (MBS) and alcohol use disorder (AUD), while the possible contribution to alcohol-related mortality remains unclear. The aim of this study...BACKGROUND: A body of evidence supports a link between metabolic bariatric surgery (MBS) and alcohol use disorder (AUD), while the possible contribution to alcohol-related mortality remains unclear. The aim of this study was to examine the association between MBS and the risk of AUD and alcohol-related mortality over up to 35 years. METHODS: The Swedish Obese Subjects (SOS) study enrolled 2007 participants with severe obesity who underwent MBS and 2040 matched controls (median follow-up 25.2 years). Patients in the surgery group underwent gastric bypass (GBP; 266 patients), gastric banding (376 patients), or vertical banded gastroplasty (VBG; 1365 patients). The matched controls received the customary treatment for severe obesity at their primary healthcare centres. Data on AUD diagnoses and alcohol-related mortality were captured from the Swedish National Patient Register and the Swedish Cause of Death Register respectively. RESULTS: During long-term follow-up, a significant difference in the incidence of AUD was found across surgery groups (log rank P < 0.001). Patients who underwent GBP exhibited the highest AUD risk (adjusted HR (HRadj) 5.07 (95% c.i. 3.11 to 8.25); P < 0.001), followed by patients who underwent VBG (HRadj 2.28 (95% c.i. 1.56 to 3.34); P < 0.001) and patients who underwent gastric banding (HRadj 2.34 (95% c.i. 1.37 to 4.01); P = 0.002), compared with usual obesity care. Alcohol-related mortality was significantly elevated after GBP (adjusted sub-HR (sub-HRadj) 6.18 (95% c.i. 2.48 to 15.40); P < 0.001) and VBG (sub-HRadj 3.56 (95% c.i. 1.79 to 7.08); P < 0.001) compared with usual obesity care. Mortality after gastric banding was also elevated, but did not reach statistical significance (sub-HRadj 2.52 (95% c.i. 0.89 to 7.15); P = 0.082). CONCLUSION: Effective management of alcohol-related complications in MBS patients requires preoperative risk assessment, postoperative monitoring, and access to targeted interventions for AUD.
BACKGROUND: Metabolic bariatric surgery (MBS) quality registries monitor various outcomes, enabling the assessment of hospital performance in comparison with national benchmarks. However, if there is considerable between...BACKGROUND: Metabolic bariatric surgery (MBS) quality registries monitor various outcomes, enabling the assessment of hospital performance in comparison with national benchmarks. However, if there is considerable between-surgeon outcome variation, surgeon-level feedback may be better suited. The aim of this study was to assess the extent to which patient-, surgeon-, and hospital-level factors contribute to the variation in outcomes after MBS. METHODS: All primary procedures registered in the Dutch MBS quality registry between 1 January 2020 and 31 December 2023 were included. Outcomes included severe postoperative complications, reoperation, prolonged length of stay (LOS), readmission, textbook outcome, and achieving ≥25% total weight loss within 1 year. Multilevel logistic regression models were built for each outcome, including all available patient characteristics, operating surgeon, and hospital, to determine the variance explained by patient-, surgeon-, and hospital-level factors. RESULTS: In total, 30 610 patients were included, operated on by 144 surgeons in 19 hospitals. Hospital-level factors contributed most to the explained variance for all outcomes, ranging from 59.6% for reoperation to 90.3% for prolonged LOS. Surgeon-level factors explained less variance, ranging from 3.2% for prolonged LOS to 28.2% for reoperation. Patient characteristics explained the least, ranging from 4.4% for textbook outcome to 13.1% for severe postoperative complications. CONCLUSION: Variation in outcomes is mostly explained by hospital factors, rather than surgeon factors, supporting hospital-based performance feedback. The results suggest that the pre- and postoperative trajectory and perioperative care may affect MBS outcomes more than patient characteristics or surgical team performance.
INTRODUCTION: The quilt technique to minimize post-mastectomy seroma has been adopted slowly due to concerns about potential long-term side effects, longer operating times, and cost-effectiveness. This study aimed to eva...INTRODUCTION: The quilt technique to minimize post-mastectomy seroma has been adopted slowly due to concerns about potential long-term side effects, longer operating times, and cost-effectiveness. This study aimed to evaluate the implementation of the quilt technique on textbook outcome in patients undergoing mastectomy. METHODS: A stepped-wedge randomized cluster trial was conducted in 12 Dutch hospitals, each representing a cluster. Patients who underwent the quilt technique after mastectomy were compared with those with conventional closure. Primary outcome was textbook outcome, defined as the absence of wound complications, readmissions, reoperations, or unscheduled outpatient visits, and no increase in pain medication use 6 months after surgery compared to preoperative use. Secondary outcomes were related to healthcare consumption and patient satisfaction. RESULTS: Two hundred and fifty-one patients who underwent mastectomy were included. The incidence of textbook outcome was higher in the quilted cohort compared to the non-quilted cohort, 94 of 143 (65.7%) versus 26 of 63 patients (41.3%, P = 0.003). Wound complications, including clinically significant seroma, were 24.0% in the quilted patients versus 55.6% in the non-quilted patients (P < 0.001). In the quilted cohort, 30.2% of patients required an unscheduled outpatient clinic visit, compared to 44.4% in the non-quilted cohort (P = 0.048). No significant differences were observed in postoperative pain, shoulder function, satisfaction and physical well-being of the chest, or cosmetic outcome. CONCLUSION: Quilting after mastectomy was superior to conventional closure in terms of textbook outcome and healthcare consumption without any undesirable side effects. TRIAL REGISTRATION NUMBER: NCT05272904, ClinicalTrials.gov.
BACKGROUND: The gut microbiome may influence postoperative outcomes after rectal cancer surgery, including anastomotic leak. However, perioperative microbiome dynamics and their association with outcomes remain poorly un...BACKGROUND: The gut microbiome may influence postoperative outcomes after rectal cancer surgery, including anastomotic leak. However, perioperative microbiome dynamics and their association with outcomes remain poorly understood. The aim of this study was to characterize changes in the rectal microbiome in patients undergoing rectal cancer surgery within the National Institute for Health and Care Research (NIHR) IntAct trial. METHODS: Rectal swabs were collected at baseline, day of surgery, and postoperative day 3-5. DNA was extracted for 16S ribosomal RNA (rRNA) sequencing and collagenase-producing organisms were identified by culture. Associations between microbiome composition and clinical variables were analysed. RESULTS: A total of 202 patients were included (mean age 65 years; 69.8% male). At baseline, smoking status explained 3.2% of variation in beta-diversity (P = 0.046). On the day of surgery, beta-diversity was associated with hospital site (11.1%; P = 0.033), mechanical bowel preparation (2.6%; P = 0.024), and preoperative oral antibiotics (1.0%; P = 0.020). After surgery, hospital site (16.3%; P < 0.001), a defunctioning stoma (2.9%; P = 0.003), and preoperative oral antibiotics (1.6%; P = 0.006) influenced beta-diversity. Alpha-diversity decreased over time, with postoperative increases in Enterococcus and Prevotella. A defunctioning stoma was associated with lower alpha-diversity and increased Pseudomonas and Streptococcus. No significant difference in alpha- or beta-diversity was observed between patients with and without anastomotic leak, although subtle differences in taxa of low abundance were detected and 43.6% of postoperative samples demonstrated collagenase activity. CONCLUSION: This is the largest study to date describing perioperative microbiome changes in patients undergoing rectal cancer surgery. Measurable shifts in the microbiome were observed, with small differences between patients with and without anastomotic leak. Further research is needed to explore the clinical significance of these microbiome changes.
INTRODUCTION: Surgical site infections (SSI) complicate at least 5% of hand trauma operations; however, the efficacy of prophylactic antibiotics remains unclear. Unlike previous meta-analyses, this network meta-analysis...INTRODUCTION: Surgical site infections (SSI) complicate at least 5% of hand trauma operations; however, the efficacy of prophylactic antibiotics remains unclear. Unlike previous meta-analyses, this network meta-analysis (NMA) provides a definitive summary of all currently available data across multiple antibiotic classes, allowing indirect comparisons to provide a robust understanding of relative antibiotic effectiveness. METHODS: A systematic literature search was performed across EMBASE, MEDLINE, CINAHL, and CENTRAL, supplemented by Google Scholar and clinical trial registries. Prospective comparative studies comparing antibiotics versus placebo/no antibiotics in patients undergoing surgery for hand and wrist trauma were included. Data on SSI rates were extracted and analysed using network meta-analysis with frequentist random-effects models. RESULTS: Some 4499 articles were screened, with 13 randomized controlled trials (RCT) and 2 non-randomized studies involving 3898 participants included in the analysis. The pooled SSI prevalence was 3.6%. Our NMA indicated that prophylactic antibiotics did not significantly reduce SSI risk compared to placebo: the highest-ranking treatment (mixed antibiotic regimen) demonstrating a relative risk of 0.29 (95% c.i. 0.04, 2.13). Subgroup analyses revealed no significant differences based on injury type or location of surgery. CONCLUSION: There was insufficient evidence to support routine prophylactic antibiotic use in hand trauma surgery. Low event rates, wide confidence intervals, and moderate-to-high risk of bias in most included studies limit the certainty of this conclusion: the evidence remains inconclusive. Future high-quality RCTs are warranted to evaluate the benefit of antibiotic prophylaxis in hand trauma surgery.
BACKGROUND: Gastroparesis is a chronic gastric motility disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Patients often experience nausea, vomiting, bloating, and early satiety...BACKGROUND: Gastroparesis is a chronic gastric motility disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Patients often experience nausea, vomiting, bloating, and early satiety. Several treatment options exist, including dietary changes, pharmacological agents, botulinum toxin injection, gastric electrical stimulation (GES), pyloroplasty, and gastric per-oral endoscopic myotomy (G-POEM). However, comparative effectiveness data are limited. METHODS: A systematic review and network meta-analysis (NMA) was conducted to evaluate the relative effectiveness of interventions for gastroparesis. A literature search in PubMed, Google Scholar, and Cochrane CENTRAL (1982 to 31 May 2024) identified studies involving adults with scintigraphically confirmed gastroparesis and symptom assessment using the Gastroparesis Cardinal Symptom Index (GCSI) or Total Symptom Score (TSS). A DerSimonian-Laird random-effects meta-analysis and NMA with standardized mean differences were performed. Treatments were ranked using P scores. RESULTS: A total of 55 studies met the inclusion criteria. G-POEM, pyloroplasty, GES, and botulinum toxin A were eligible for quantitative analysis. All interventions showed significant short-term symptom improvement. G-POEM had the greatest short-term effect and improved gastric emptying. At intermediate follow-up (>3-36 months), GES showed the highest efficacy. Long-term data (>36 months) were only available for G-POEM. GES was the only intervention assessed in sham-controlled trials, demonstrating superiority over placebo. CONCLUSION: G-POEM and GES are the most effective treatments for gastroparesis. These findings support a tiered approach, integrating G-POEM for short-term symptom relief and GES for sustained improvement, depending on the clinical setting and availability.
BACKGROUND: The RAPIDO trial compared total neoadjuvant treatment (TNT) with preoperative chemoradiotherapy (CRT), both followed by total mesorectal excision, in patients with locally advanced rectal cancer (LARC). A hig...BACKGROUND: The RAPIDO trial compared total neoadjuvant treatment (TNT) with preoperative chemoradiotherapy (CRT), both followed by total mesorectal excision, in patients with locally advanced rectal cancer (LARC). A higher locoregional recurrence (LRR) rate was observed after TNT. This study investigates factors contributing to the difference in LRR observed. METHOD: Patients with high-risk LARC received TNT (5 × 5 Gy followed by 6 × CAPOX or 9 × FOLFOX4) or CRT (25-28 × 1.8-2 Gy with concurrent capecitabine). Patients with a local R0 or R1 resection were included in this study. Sphincter-preserving surgery encompassed (low) anterior resection and Hartmann's procedure. The influence of baseline, surgical and pathological factors on LRR was evaluated. RESULTS: Of 920 randomized patients, 849 (430 versus 419 in the TNT and CRT arms) were eligible. The cumulative incidence of LRR at 8 years was 10.8% after TNT and 5.8% after CRT (HR 1.91). Following sphincter preserving surgery, 12.1% (TNT) and 4.8% (CRT) developed LRR (HR 2.60), compared to 8.5% versus 7.5%, respectively, after abdominoperineal resection. Distal resection margin rates (DRM) of 10 mm or less after sphincter-preserving surgery were similar in both arms (TNT 17.5% versus CRT 22.1%). However, a higher cumulative incidence of LRR was observed with a DRM of 10 mm or less after TNT (25.4% versus 1.8%; HR 15.51). Other factors were similar between treatment arms with respect to LRR. CONCLUSION: The difference in LRR between TNT and CRT mainly occurred in patients treated with sphincter-preserving surgery. Baseline information on the original tumour bed should be considered when determining the surgical approach after total neoadjuvant treatment.
BACKGROUND: Upfront portal vein embolization (PVE) without prior future liver remnant (FLR) clearing followed by a one-stage hepatectomy (OSH) for bilateral colorectal liver metastases (CRLM) can reduce the surgical burd...BACKGROUND: Upfront portal vein embolization (PVE) without prior future liver remnant (FLR) clearing followed by a one-stage hepatectomy (OSH) for bilateral colorectal liver metastases (CRLM) can reduce the surgical burden of a two-stage approach, but oncological safety is not well described and comparisons with alternative two-stage procedures are lacking. METHODS: A retrospective cohort of patients with bilateral CRLM and tumour in the FLR, undergoing liver resection between 2013 and 2021, was studied. The patients were divided into three groups: patients who underwent PVE with no prior tumour clearance in the FLR followed by an OSH (PVE-OSH); patients who underwent tumour clearance in the FLR followed by PVE (TSH-PVE; where TSH stands for two-stage hepatectomy); and patients who underwent associating liver partition and portal vein ligation for staged hepatectomy (ALPPS). RESULTS: In total, 302 patients with bilateral CRLM were included, of whom 127 underwent PVE-OSH, 61 underwent TSH-PVE, and 114 underwent ALPPS. Except for age and Eastern Cooperative Oncology Group (ECOG) Performance Status, all baseline characteristics were comparable. The most rapid hypertrophy was experienced by ALPPS patients, followed by PVE-OSH patients. Successful resection could not be performed in 11% of PVE-OSH patients, 21% of TSH-PVE patients, and 4% of ALPPS patients (P < 0.001). During major resection, 23% of TSH-PVE patients required additional FLR resection/ablation and the median time from first intervention to major resection was 9 (interquartile range (i.q.r.) 7-13) weeks, compared with 6 (i.q.r. 5-8) weeks for PVE-OSH patients and 1 (i.q.r. 1-3) week for ALPPS patients (P < 0.001). Postoperative outcomes were comparable regarding liver failure, mortality, and overall survival. Multivariable regression analysis for liver recurrence identified the number of metastases (HR 1.04 (95% c.i. 1.00 to 1.07); P = 0.025) and ALPPS (HR 1.64 (95% c.i. 1.00 to 2.68); P = 0.048) as independent risk factors. CONCLUSION: PVE-OSH can be performed safely for patients with a limited tumour burden in the FLR, thereby obviating the need for two-stage procedures.
Kapalla M, Stoklasa K, Zlatanovic P
… +8 more, Sieber S, Doukas P, Caradu C, Noronen K, Enzmann FK, Gratl A, Busch A, European Vascular Research Collaborative (EVRC)
Hallet J, Acher AW, Jivraj N
… +11 more, McIsaac DI, Carrier FM, Turgeon AF, Flexman A, Lorello GR, Chan WC, Gombay A, Ding A, Armah J, Eskander A, Sutradhar R
BACKGROUND: Completion axillary lymph node dissection (cALND) is often recommended for patients with isolated tumour cells (ITCs) or micrometastases in the sentinel lymph node (SLN) or target lymph node (TLN) to assess t...BACKGROUND: Completion axillary lymph node dissection (cALND) is often recommended for patients with isolated tumour cells (ITCs) or micrometastases in the sentinel lymph node (SLN) or target lymph node (TLN) to assess the definite nodal tumour burden after neoadjuvant chemotherapy (NACT). The aim of this study was to investigate the upgrade of N stage by cALND in patients with low-volume metastases in the SLN/TLN after NACT from the prospective, international, multicentre AXSANA cohort study. METHODS: NACT-treated patients that converted from a positive to a negative clinical lymph node status and underwent cALND based on low-volume SLN/TLN involvement were included. The association between the final N stage, the pathological tumour response in the breast, and the clinical impact of cALND on post-NACT treatment decisions was determined. RESULTS: Among 5329 patients recruited between June 2020 and March 2024, 2194 were scheduled for SLN biopsy (SLNB), targeted axillary dissection (TAD), or TLN biopsy (TLNB). Among 16 patients with ypN0i+(SLN/TLN), one patient was upgraded to ypN1a by cALND, while five of the 71 patients with ypN1mi(SLN/TLN) were upstaged to ypN2 and one of the 71 patients with ypN1mi(SLN/TLN) was upstaged to ypN3. None of these patients had a pCR in the breast and thus nodal upstaging had no impact on post-NACT treatment decisions. CONCLUSION: Despite substantial additional nodal involvement in low-volume SLN/TLN disease, cALND does not provide clinically meaningful information for post-NACT systemic treatment modifications and should not be encouraged for diagnostic purposes alone.
BACKGROUND: Around 15% of people with colon cancer present with an obstruction. Stenting is appropriate for patients unfit for surgery and/or those with advanced cancer. Patients are living longer with advanced colon can...BACKGROUND: Around 15% of people with colon cancer present with an obstruction. Stenting is appropriate for patients unfit for surgery and/or those with advanced cancer. Patients are living longer with advanced colon cancer; stent design (covered versus uncovered) may influence stent re-intervention and quality of life (QoL). METHODS: CReST2 is a phase III multicentre RCT. Patients were randomized 1 : 1 to receive either a covered or uncovered stent. Patients and all medical personnel except the person placing the stent were blinded to allocation. Treatment allocation was via a central randomization service, minimized for: age (≤70 years, >70 years), WHO performance status, tumour site, and indication for palliation. Co-primary endpoints were stent patency up to 6 months after randomization and QoL at 3 months (30 days for patients who died before 3 months) from randomization measured using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health score. Secondary endpoints were stenting success rate, rates of short-term (30 days), intermediate-term (1-3 months), and long-term (3-6 months) stent-related complications, stent-related complication rates of patients undergoing chemotherapy within 6 months after randomization, cumulative frequency of stoma formation, survival at 6 months, and overall survival. RESULTS: A total of 377 patients were randomised across 28 sites, in whom stenting was unsuccessful in 47 (12.5%) patients (27 of 188: 14.4% covered and 20 of 186: 10.7% uncovered stents). Stent patency at 6 months in stented patients was 117 of 161 (72.7%, covered) and 136 of 166 (81.9%, uncovered) (adjusted HR 1.48, 97.5% confidence interval (c.i.): 0.86-2.54). In this stented population, 216 patients (66.1%) contributed to QoL assessment at 3 months with mean(s.d.) QLQ-C30 global health scores of 54.1(23.9) and 51.6(25.4) in the covered and uncovered groups respectively (adjusted mean difference 1.63, 97.5% c.i. -5.85-9.11). The total numbers of patients experiencing at least one complication in the first 6 months after randomization were 42 of 161 (26.1%) for covered stents and 29 of 166 (17.5%) for uncovered stents. Stent migration was the most common complication and was higher in the covered group. In the covered group and the uncovered group, 44 of 161 (27.3%) and 40 of 166 (24.1%) patients respectively received chemotherapy up to 6 months after randomization. There was a low risk of late perforation associated with both types of stent. CONCLUSION: There appears to be greater prolonged stent patency and less stent failure with uncovered stents. QoL is unaffected by stent design. REGISTRATION NUMBER: ISRCTN54834267.