Randomized controlled trial of nasogastric tube use after esophagectomy: study protocol for the kinetic trial.

Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.

Long-term Follow-up 15 Years After Duodenal Switch or Gastric Bypass for Super Obesity: a Randomized Controlled Trial.

BACKGROUND: In super obesity, Roux-en-Y gastric bypass (RYGB) may be insufficient why some surgeons advocate biliopancreatic diversion with duodenal switch (BPD/DS), a more malabsorptive procedure. There is a paucity of evidence regarding results beyond 10 years, especially after BPD/DS. The aim of this randomized controlled trial was to compare the long-term outcome of BPD/DS, and RYGB in patients with super obesity, i.e., body mass index (BMI) > 50 kg/m2. METHODS: This is a 13- to 17-year follow-up study of a single-center, single-blinded randomized trial in which 47 patients (BMI > 48 and eligible for bariatric surgery) were randomized 1:1 to BPD/DS and RYGB (25 men, 24 BPD/DS, 39.1 ± 9.9 years, BMI 54.5 ± 6.1 kg/m2). The primary outcome was weight loss. The study was financed by Swedish governmental funding of clinical research (ALF). TRIAL REGISTRATION NUMBER: ISRCTN10940791. RESULTS: Thirty-four (18 BPD/DS) of the living 42 patients (81.0%) participated. BPD/DS resulted in higher BMI loss (20.4 ± 7.9 vs. 12.4 ± 8.6, p = .008) and higher percent of total body weight loss (37.5% ± 12.2 vs. 22.8% ± 14.8, p = .004). BPD/DS was associated with lower fasting glucose, glycated hemoglobin (HbA1c), and low-density lipoprotein (LDL) as well as lower hemoglobin. Adverse events were more common after BPD/DS (2.7 vs. 0.9 per patient, p = .004). The global assessment tool BAROS (Bariatric Analysis and Reporting Outcome System) demonstrated superior scores for BPD/DS (p = .047). CONCLUSION: When compared to RYGB, BPD/DS results in superior weight loss and metabolic control as well as superior BAROS score, however, at the cost of more adverse events.

Aspirin or statin use in relation to survival after surgery for esophageal cancer: a population-based cohort study.

BACKGROUND: Adjuvant postoperative treatment with aspirin and statins may improve survival in several solid tumors. This study aimed to assess whether these medications improve the survival after curatively intended treatment (including esophagectomy) for esophageal cancer in an unselected setting. METHODS: This nationwide cohort study included nearly all patients who underwent esophagectomy for esophageal cancer in Sweden from 2006 to 2015, with complete follow-up throughout 2019. Risk of 5-year disease-specific mortality in users compared to non-users of aspirin and statins was analyzed using Cox regression, providing hazard ratios (HR) with 95% confidence intervals (CI). The HRs were adjusted for age, sex, education, calendar year, comorbidity, aspirin/statin use (mutual adjustment), tumor histology, pathological tumor stage, and neoadjuvant chemo(radio)therapy. RESULTS: The cohort included 838 patients who survived at least 1 year after esophagectomy for esophageal cancer. Of these, 165 (19.7%) used aspirin and 187 (22.3%) used statins during the first postoperative year. Neither aspirin use (HR 0.92, 95% CI 0.67-1.28) nor statin use (HR 0.88, 95% CI 0.64-1.23) were associated with any statistically significant decreased 5-year disease-specific mortality. Analyses stratified by subgroups of age, sex, tumor stage, and tumor histology did not reveal any associations between aspirin or statin use and 5-year disease-specific mortality. Three years of preoperative use of aspirin (HR 1.26, 95% CI 0.98-1.65) or statins (HR 0.99, 95% CI 0.67-1.45) did not decrease the 5-year disease-specific mortality. CONCLUSIONS: Use of aspirin or statins might not improve the 5-year survival in surgically treated esophageal cancer patients.

Improved survival after laparoscopic compared to open gastrectomy for advanced gastric cancer: a Swedish population-based cohort study.

BACKGROUND: Laparoscopic gastrectomy is increasingly used for the treatment of locally advanced gastric cancer but concerns remain whether similar results can be obtained compared to open gastrectomy, especially in Western populations. This study compared the short-term postoperative, oncological and survival outcomes following laparoscopic versus open gastrectomy based on data from the Swedish National Register for Esophageal and Gastric Cancer. METHODS: Patients who underwent surgery with curative intent for adenocarcinoma of the stomach or gastroesophageal junction Siewert type III from 2015 to 2020 were identified, and 622 patients with cT2-4aN0-3M0 tumors were included. The impact of surgical approach on short-term outcomes was assessed using multivariable logistic regression. Long-term survival was compared using multivariable Cox regression. RESULTS: In total, 350 patients underwent open and 272 laparoscopic gastrectomy, of which 12.9% were converted to open surgery. The groups were similar regarding distribution of clinical disease stage (27.6% stage I, 46.0% stage II, and 26.4% stage III). Neoadjuvant chemotherapy was administered to 52.7% of the patients. There was no difference in the rate of postoperative complications, but laparoscopic approach was associated with lower 90 day mortality (1.8 vs 4.9%, p = 0.043). The median number of resected lymph nodes was higher after laparoscopic surgery (32 vs 26, p < 0.001), while no difference was found in the rate of tumor-free resection margins. Better overall survival was observed after laparoscopic gastrectomy (HR 0.63, p < 0.001). CONCLUSIONS: Laparoscopic gastrectomy can be safely preformed for advanced gastric cancer and is associated with improved overall survival compared to open surgery.

Extent of Lymphadenectomy and Long-term Survival in Esophageal Cancer.

OBJECTIVE: To examine the hypothesis that survival in esophageal cancer increases with more removed lymph nodes during esophagectomy up to a plateau, after which it levels out or even decreases with further lymphadenec-tomy. SUMMARY OF BACKGROUND DATA: There is uncertainty regarding the ideal extent of lymphadenectomy during esophagectomy to optimize long-term survival in esophageal cancer. METHODS: This population-based cohort study included almost every patient who underwent esophagectomy for esophageal cancer in Sweden or Finland in 2000-2016 with follow-up through 2019. Degree of lymphadenectomy, divided into deciles, was analyzed in relation to all-cause 5-year mortality. Multivariable Cox regression provided hazard ratios (HR) with 95% confidence intervals (95% CI) adjusted for all established prognostic factors. RESULTS: Among 2306 patients, the second (4-8 nodes), seventh (21-24 nodes) and eighth decile (25-30 nodes) of lymphadenectomy showed the lowest all-cause 5-year mortality compared to the first decile [hazard ratio (HR) = 0.77, 95% CI 0.61-0.97, HR = 0.76, 95% CI 0.59-0.99, and HR = 0.73, 95% CI 0.57-0.93, respectively]. In stratified analyses, the survival benefit was greatest in decile 7 for patients with pathological T-stage T3/T4 (HR = 0.56, 95% CI0.40-0.78), although it was statistically improved in all deciles except decile 10. For patients without neoadjuvant chemotherapy, survival was greatest in decile 7 (HR = 0.60, 95% CI 0.41-0.86), although survival was also statistically significantly improved in deciles 2, 6, and 8. CONCLUSION: Survival in esophageal cancer was not improved by extensive lymphadenectomy, but resection of a moderate number (20-30) of nodes was prognostically beneficial for patients with advanced T-stages (T3/T4) and those not receiving neoadjuvant therapy.

Neoadjuvant Chemoradiotherapy and Surgery for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed: The Study Protocol for the Randomized Controlled NEEDS Trial.

Background: The globally dominant treatment with curative intent for locally advanced esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemoradiotherapy (nCRT) with subsequent esophagectomy. This multimodal treatment leads to around 60% overall 5-year survival, yet with impaired post-surgical quality of life. Observational studies indicate that curatively intended chemoradiotherapy, so-called definitive chemoradiotherapy (dCRT) followed by surveillance of the primary tumor site and regional lymph node stations and surgery only when needed to ensure local tumor control, may lead to similar survival as nCRT with surgery, but with considerably less impairment of quality of life. This trial aims to demonstrate that dCRT, with selectively performed salvage esophagectomy only when needed to achieve locoregional tumor control, is non-inferior regarding overall survival, and superior regarding health-related quality of life (HRQOL), compared to nCRT followed by mandatory surgery, in patients with operable, locally advanced ESCC. Methods: This is a pragmatic open-label, randomized controlled phase III, multicenter trial with non-inferiority design with regard to the primary endpoint overall survival and a superiority hypothesis for the experimental intervention dCRT with regard to the main secondary endpoint global HRQOL one year after randomization. The control intervention is nCRT followed by preplanned surgery and the experimental intervention is dCRT followed by surveillance and salvage esophagectomy only when needed to secure local tumor control. A target sample size of 1200 randomized patients is planned in order to reach 462 events (deaths) during follow-up. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04460352.

Identifying a core symptom set triggering radiological and endoscopic investigations for suspected recurrent esophago-gastric cancer: a modified Delphi consensus process.

BACKGROUND: There is currently a lack of evidence-based guidelines regarding surveillance for recurrence after esophageal and gastric (OG) cancer surgical resection, and which symptoms should prompt endoscopic or radiological investigations for recurrence. The aim of this study was to develop a core symptom set using a modified Delphi consensus process that should guide clinicians to carry out investigations to look for suspected recurrent OG cancer in previously asymptomatic patients. METHODS: A web-based survey of 42 questions was sent to surgeons performing OG cancer resections at high volume centers. The first section evaluated the structure of follow-up and the second, determinants of follow-up. Two rounds of a modified Delphi consensus process and a further consensus workshop were used to determine symptoms warranting further investigations. Symptoms with a 75% consensus agreement as suggestive of recurrent cancer were included in the core symptom set. RESULTS: 27 surgeons completed the questionnaires. A total of 70.3% of centers reported standardized surveillance protocols, whereas 3.7% of surgeons did not undertake any surveillance in asymptomatic patients after OG cancer resection. In asymptomatic patients, 40.1% and 25.9% of centers performed routine imaging and endoscopy, respectively. The core set that reached consensus, consisted of eight symptoms that warranted further investigations included; dysphagia to solid food, dysphagia to liquids, vomiting, abdominal pain, chest pain, regurgitation of foods, unexpected weight loss and progressive hoarseness of voice. CONCLUSION: There is global variation in monitoring patients after OG cancer resection. Eight symptoms were identified by the consensus process as important in prompting radiological or endoscopic investigation for suspected recurrent malignancy. Further randomized controlled trials are necessary to link surveillance strategies to survival outcomes and evaluate prognostic value.

Population-Based Cohort Study from a Prospective National Registry: Better Long-Term Survival in Esophageal Cancer After Minimally Invasive Compared with Open Transthoracic Esophagectomy.

BACKGROUND: Recent research indicates long-term survival benefits of minimally invasive esophagectomy (MIE) compared with open esophagectomy (OE) for patients with esophageal and gastroesophageal junction (GEJ) cancers, but there is a need for more population-based studies. METHODS: We conducted a prospective population-based nationwide cohort study including all patients in Sweden diagnosed with esophageal or junctional cancer who underwent a transthoracic esophagectomy with intrathoracic anastomosis. Data were collected from the Swedish National Register for Esophageal and Gastric Cancer in 2006-2019. Patients were grouped into OE and MIE including hybrid MIE (HMIE) and totally MIE (TMIE). Overall survival and short-term postoperative outcomes were compared using Cox regression and logistic regression models, respectively. All models were adjusted for age, sex, American Society of Anesthesiologists (ASA) score, clinical T and N stage, neoadjuvant therapy, year of surgery, and hospital volume. RESULTS: Among 1404 patients, 998 (71.1%) underwent OE and 406 (28.9%) underwent MIE. Compared with OE, overall survival was better following MIE (hazard ratio [HR] 0.72, 95% confidence interval [CI] 0.55-0.94), TMIE (HR 0.67, 95% CI 0.47-0.94), and possibly also after HMIE (HR 0.76, 95% CI 0.56-1.02). MIE was associated with shorter operation time, less intraoperative bleeding, higher number of resected lymph nodes, and shorter hospital stay compared with OE. MIE was also associated with fewer overall complications (odds ratio [OR] 0.70, 95% CI 0.47-1.03) as well as non-surgical complications (OR 0.64, 95% CI 0.40-1.00). CONCLUSIONS: MIE seems to offer better survival and similar or improved short-term postoperative outcomes in esophageal and GEJ cancers compared with OE in this unselected population-based cohort.

Health-related quality of life one year after the diagnosis of oesophageal cancer: a population-based study from the Swedish National Registry for Oesophageal and Gastric Cancer.

BACKGROUND: Population-based patient reported outcome data in oesophageal cancer are rare. The main purpose of this study was to describe health-related quality of life (HRQOL) 1 year after the diagnosis of oesophageal cancer, comparing subgroups of curatively and palliatively managed patients. METHODS: This is a nationwide population-based cohort study, based on the Swedish National Registry for Oesophageal and Gastric Cancer (NREV) with prospectively registered data, including HRQOL instruments from the European Organisation for Research and Treatment of Cancer including the core and disease specific questionnaires (EORTC QLQ-C30 and QLQ-OG25). Patients diagnosed with oesophageal cancer between 2009 and 2016 and with complete HRQOL data at 1 year follow-up were included. HRQOL of included patients was compared to a reference population matched by age and gender to to a previous cohort of unselected Swedish oesophageal cancer patients. Linear regression was performed to calculate mean scores with 95% confidence intervals (CI) and adjusted linear regression analysis was used to calculate mean score differences (MD) with 95% CI. RESULTS: A total of 1156 patients were included. Functions and global health/quality of life were lower in both the curative and palliative cohorts compared to the reference population. Both curatively and palliatively managed patients reported a severe symptom burden compared to the reference population. Patients who underwent surgery reported more problems with diarrhoea compared to those treated with definitive chemoradiotherapy (dCRT) (MD -14; 95% CI - 20 to - 8). Dysphagia was more common in patiens treated with dCRT compared to surgically treated patients (MD 11; 95% CI 4 to 18). Those with palliative intent due to advanced tumour stage reported more problems with dysphagia compared to those with palliative intent due to frailty (MD -18; 95% CI - 33 to - 3). CONCLUSIONS: One year after diagnosis both curative and palliative intent patients reported low function scores and severe symptoms. Dysphagia, choking, and other eating related problems were more pronounced in palliatively managed patients and in the curative intent patients treated with dCRT.

Quantitative comparison of data-driven gating and external hardware gating for 18F-FDG PET-MRI in patients with esophageal tumors.

BACKGROUND: Respiratory motion during PET imaging reduces image quality. Data-driven gating (DDG) based on principal component analysis (PCA) can be used to identify respiratory signals. The use of DDG, without need for external devices, would greatly increase the feasibility of using respiratory gating in a routine clinical setting. The objective of this study was to evaluate data-driven gating in relation to external hardware gating and regular static image acquisition on PET-MRI data with respect to SUVmax and lesion volumes. METHODS: Sixteen patients with esophageal or gastroesophageal cancer (Siewert I and II) underwent a 6-min PET scan on a Signa PET-MRI system (GE Healthcare) 1.5-2 h after injection of 4 MBq/kg 18F-FDG. External hardware gating was done using a respiratory bellow device, and DDG was performed using MotionFree (GE Healthcare). The DDG raw data files and the external hardware-gating raw files were created on a Matlab-based toolbox from the whole 6-min scan LIST-file. For comparison, two 3-min static raw files were created for each patient. Images were reconstructed using TF-OSEM with resolution recovery with 2 iterations, 28 subsets, and 3-mm post filter. SUVmax and lesion volume were measured in all visible lesions, and noise level was measured in the liver. Paired t-test, linear regression, Pearson correlation, and Bland-Altman analysis were used to investigate difference, correlation, and agreement between the methods. RESULTS: A total number of 30 lesions were included in the study. No significant differences between DDG and external hardware-gating SUVmax or lesion volumes were found, but the noise level was significantly reduced in the DDG images. Both DDG and external hardware gating demonstrated significantly higher SUVmax (9.4% for DDG, 10.3% for external hardware gating) and smaller lesion volume (- 5.4% for DDG, - 6.6% for external gating) in comparison with non-gated static images. CONCLUSIONS: Data-driven gating with MotionFree for PET-MRI performed similar to external device gating for esophageal lesions with respect to SUVmax and lesion volume. Both gating methods significantly increased the SUVmax and reduced the lesion volume in comparison with non-gated static acquisition. DDG resulted in reduced image noise compared to external device gating and static images.

Peri-anastomotic microdialysis lactate assessment after esophagectomy.

BACKGROUND: Esophagectomy is the cornerstone in curative treatment for esophageal and gastroesophageal junctional cancer. Esophageal resection is an advanced procedure with many complications, whereof anastomotic leak is the most dreaded. This study aimed to monitor the microcirculation with microdialysis analysis of local lactate levels in real-time on both sides of the esophagogastric anastomosis in totally minimally invasive Ivor-Lewis esophagectomy. MATERIALS AND METHODS: Twenty-five patients planned for esophageal resection with gastric conduit reconstruction and intrathoracic anastomosis were recruited. A sampling device, the OnZurf® Probe, along with the CliniSenz® Analyser (Senzime AB, Uppsala Sweden) was utilized for measurements. Lactate levels from both sides of the anastomosis were analysed in real time, on site, by a transportable analyser device. Measurements were made every 30 min during the first 24 h, and thereafter every 2 hours for up to 4 days. RESULTS: All probes could be positioned as planned and on the third postoperative day 19/25 and 15/25 of the esophageal and gastric probes, respectively, continued to deliver measurements. In total, 89.6% (1539/1718) and 72.4% (1098/1516) of the measurements were deemed successful. The average lactate level on the esophageal side of the anastomosis and the gastric conduit ranged between 1.1-11.5 and 0.8-7.0 mM, respectively. Two anastomotic leaks occurred, one of which had persisting high lactate levels on the gastric side of the anastomosis. CONCLUSION: Application and use of the novel CliniSenz® analyser system, in combination with the OnZurf® Probe was feasible and safe. Continuous monitoring of analytes from the perianastomotic area has the potential to improve care after esophageal resection.

Risk of Permanent Hypoparathyroidism After Total Thyroidectomy for Benign Disease: A Nationwide Population-based Cohort Study From Sweden.

OBJECTIVE: To investigate the prevalence and risk factors for permanent hypoparathyroidism after total thyroidectomy for benign disease in a population-based setting with data independent of input of complication data. SUMMARY OF BACKGROUND DATA: The reported rate of permanent hypoparathyroidism is highly variable and mostly rely on reported complication data from national or institutional registries. METHODS: All patients who underwent total thyroidectomy in Sweden from 2005 to 2015 were identified through Scandinavian Quality Register for Thyroid, Parathyroid and Adrenal Surgery and the Swedish National Patient Register. Patients were matched to outcome data from the Swedish Prescribed Drug Register. Permanent hypoparathyroidism was defined as treatment with calcium and/or active vitamin D more than 1 year after surgery. RESULTS: Seven thousand eight hundred fifty-two patients were included and 938 (12.5%) developed permanent hypoparathyroidism. The risk was lower in patients registered in the quality register (11.0% vs 16%, P < 0.001). In a multivariable analysis there was a higher risk of permanent hypoparathyroidism in patients with parathyroid autotransplantation [Odds ratio (OR) 1.72; 95% confidence interval 1.47-2.01], center-volume <100 thyroidectomies per year (OR 1.22; 1.03-1.44), age above 60 year (OR 1.64; 1.36-1.98) and female sex (OR 1.27; 1.05-1.54). Reported data from the quality register only identified 178 of all 938 patients with permanent hypoparathyroidism. CONCLUSION: The risk of permanent hypoparathyroidism after total thyroidectomy was high and associated with parathyroid autotransplantation, higher age, female sex and surgery at a low volume center. Reported follow-up data might underestimate the rate of permanent hypoparathyroidism.

Risk of Delayed Discharge and Reoperation of Gastric Bypass Patients with Psychiatric Comorbidity-a Nationwide Cohort Study.

BACKGROUND: Gastric bypass (GBP) surgery is considered a safe and effective treatment for obesity. However, there is uncertainty regarding the impact of preexisting psychiatric comorbidity on GBP complications. We have investigated whether a psychiatric diagnosis before GBP surgery is associated with delayed discharge (the odds of being in the 90th percentile of length of stay) and rate of reoperation in a nationwide Swedish cohort. METHODS: Patients undergoing GBP surgery during 2008-2012 were identified and followed up through the National Patient Register and the Prescribed Drug Register. Logistic regression models were fitted to the studied outcomes. RESULTS: Among the 22,539 patients identified, a prior diagnosis of bipolar disorder, schizophrenia, depression, neurotic disorders, ADHD (attention deficit hyperactivity disorder), substance use disorder, eating disorder, personality disorder, or self-harm since 1997 (n = 9480) was found to be associated with delayed discharge after GBP surgery (odds ratio [OR] = 1.47, confidence interval [CI] 1.34-1.62), especially in patients with psychiatric hospitalization exceeding 1 week in the 2 years preceding GBP surgery (OR = 2.06, CI 1.30-3.28), compared with those not hospitalized within psychiatry. Likewise, patients with a prior psychiatric diagnosis were more likely to be reoperated within 30 days (OR = 1.25, CI 1.11-1.41), with twice the likelihood OR 2.23 (CI 1.26-3.92) for patients with psychiatric hospitalization of up to a week in the 2 years preceding GBP surgery, compared with patients who had not been hospitalized within psychiatry. CONCLUSIONS: A psychiatric diagnosis before GBP surgery was associated with delayed discharge and increased likelihood of reoperation within 30 days. Patients with a prior psychiatric diagnosis may, therefore, need additional attention and support.

Prevalence and impact of acid-related symptoms and diarrhea in patients undergoing Roux-en-Y gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.

BACKGROUND: Gastrointestinal symptoms are common in the obese population. OBJECTIVES: To determine the prevalence and importance of acid-related symptoms and diarrhea in 3 different types of bariatric operations: Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and biliopancreatic diversion with duodenal switch (BPD/DS). SETTING: National data from Sweden. METHODS: A total of 58,823 primary bariatric procedures (RYGB: 87.5%, SG: 11.7%, and BPD/DS: .7%) performed from 2007 to 2017 were identified in the Scandinavian Obesity Surgery Registry. Associations between acid-related symptoms and diarrhea, both defined by continuous use of pharmacologic treatment, and predefined outcomes were studied in a multivariate model, adjusted for age, sex, body mass index, and year of surgery. RESULTS: At baseline, acid-related symptoms were most common in RYGB (9.9%), while diarrhea was rare. In general, symptomatic patients were older, had more co-morbidities, and scored lower on quality of life compared with the remaining patients. In the multivariate analysis, RYGB patients with acid-related symptoms had reduced risk of prolonged operative time and length of stay, while postoperative complications and reoperations increased by 24% and 36%, respectively. In SG, both symptoms were associated with prolonged operative time and a doubled risk for complications. Symptomatic patients had reduced improvement in quality of life, while no association with the weight result was seen. Postoperatively, acid-related symptoms decreased in RYGB, while doubling in SG. Diarrhea increased 2- and 6-fold in RYGB and BPD/DS, respectively. CONCLUSION: The 2 gastrointestinal symptoms were associated with increased operative risks and reduced improvement in quality of life. Postoperatively, the respective anatomic alternations affected both gastrointestinal symptoms.

Patient-reported experience and outcome measures during treatment for gastroesophageal cancer.

OBJECTIVE: Gastroesophageal cancer has high mortality, and continuous assessment of patient-reported data is salient for optimisation of supportive care. We aimed to evaluate our multidisciplinary concept with respect to patient-reported variables. METHODS: At diagnosis and later during the treatment, three areas of patient-reported measures were evaluated: the given information and care, fatigue (Multidimensional Fatigue Inventory [MFI-20]), dysphagia (Ogilvie dysphagia score) and weight loss. RESULTS: Of 130 outpatients, planned for a surgical procedure and given a contact nurse (CN), 106 responded. During treatment, 81% of the patients were satisfied with their CN. The given information was considered very good or good by >90% and easily understood. Half of the patients reported need for supportive care, which was rated good by 85%. All dimensions of the MFI-20 test, except mental fatigue, worsened during the treatment period. At diagnosis, 61% of the patients experienced eating problems, leading to 7% weight loss. Although dysphagia improved, weight loss reached 13% at the end of treatment. CONCLUSION: A multidisciplinary concept can be of value in giving appropriate and understandable information, leading to high satisfaction with the provided care. However, as fatigue and weight loss increased during the treatment period, patients need structured multidisciplinary support.

Patient education-level affects treatment allocation and prognosis in esophageal- and gastroesophageal junctional cancer in Sweden.

BACKGROUND: Low socioeconomic status and poor education elevate the risk of developing esophageal- and junctional cancer. High education level also increases survival after curative surgery. The present study aimed to investigate associations, if any, between patient education-level and treatment allocation after diagnosis of esophageal- and junctional cancer and its subsequent impact on survival. METHODS: A nation-wide cohort study was undertaken. Data from a Swedish national quality register for esophageal cancer (NREV) was linked to the National Cancer Register, National Patient Register, Prescribed Drug Register, Cause of Death Register and educational data from Statistics Sweden. The effect of education level (low; ≤9 years, intermediate; 10-12 years and high >12 years) on the probability of allocation to curative treatment was analyzed with logistic regression. The Kaplan-Meier-method and Cox proportional hazard models were used to assess the effect of education on survival. RESULTS: A total of 4112 patients were included. In a multivariate logistic regression model, high education level was associated with greater probability of allocation to curative treatment (adjusted OR: 1.48, 95% CI: 1.08-2.03, p = 0,014) as was adherence to a multidisciplinary treatment-conference (adjusted OR: 3.13, 95% CI: 2.40-4.08, p < 0,001). High education level was associated with improved survival in the patients allocated to curative treatment (HR: 0.82, 95% CI: 0.69-0.99, p = 0,036). DISCUSSION: In this nation-wide cohort of esophageal- and junctional cancer patients, including data regarding many confounders, high education level was associated with greater probability of being offered curative treatment and improved survival.

Changes in bowel habits and patient-scored symptoms after Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch.

BACKGROUND: Bariatric procedures are increasingly being used, but data on bowel habits are scarce. OBJECTIVES: To assess changes in gastrointestinal function and patient-scored symptoms after Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion with duodenal switch (BPD/DS). SETTING: University hospital in Sweden. METHODS: We recruited 268 adult patients (mean age of 42.5 yr, body mass index 44.8, 67.9% female) listed for RYGB and BPD/DS. Patients answered validated questionnaires prospectively concerning bowel function, the Fecal Incontinence Quality of Life Scale, and the 36-Item Short Form Health Survey before and after their operation. RESULTS: Postoperatively, 208 patients (78.2% of 266 eligible patients) answered the questionnaires. RYGB patients had fewer bowel motions per week (8 versus 10) and more abdominal pain postoperatively (P<.001). Postoperatively, the 35 BPD/DS patients (69% versus 23%) needed to empty their bowel twice or more than twice daily, reported more flatus and urgency, and increased need for keeping a diet (P<.001). Concerning Fecal Incontinence Quality of Life Scale, coping and behavior was slightly reduced while depression and self-perception scores were improved after RYGB. Lifestyle, coping and behavior, and embarrassment were reduced after BPD/DS (P<.05). In the 36-Item Short Form Health Survey, physical scores were markedly improved, while mental scores were largely unaffected. CONCLUSION: RYGB resulted in a reduced number of bowel movements but increased problems with abdominal pain. In contrast, BPD/DS-patients reported higher frequency of bowel movements, more troubles with flatus and urgency, and increased need for keeping a diet. These symptoms affected quality of life negatively, however, general quality of life was markedly improved after both procedures. These results will be of great value for preoperative counseling.

Low-Dose Aspirin Discontinuation and Risk of Cardiovascular Events: A Swedish Nationwide, Population-Based Cohort Study.

BACKGROUND: There are increasing concerns about risks associated with aspirin discontinuation in the absence of major surgery or bleeding. We investigated whether long-term low-dose aspirin discontinuation and treatment gaps increase the risk of cardiovascular events. METHODS: We performed a cohort study of 601 527 users of low-dose aspirin for primary or secondary prevention in the Swedish prescription register between 2005 and 2009 who were >40 years of age, were free from previous cancer, and had ≥80% adherence during the first observed year of treatment. Cardiovascular events were identified with the Swedish inpatient and cause-of-death registers. The first 3 months after a major bleeding or surgical procedure were excluded from the time at risk. RESULTS: During a median of 3.0 years of follow-up, 62 690 cardiovascular events occurred. Patients who discontinued aspirin had a higher rate of cardiovascular events than those who continued (multivariable-adjusted hazard ratio, 1.37; 95% confidence interval, 1.34-1.41), corresponding to an additional cardiovascular event observed per year in 1 of every 74 patients who discontinue aspirin. The risk increased shortly after discontinuation and did not appear to diminish over time. CONCLUSIONS: In long-term users, discontinuation of low-dose aspirin in the absence of major surgery or bleeding was associated with a >30% increased risk of cardiovascular events. Adherence to low-dose aspirin treatment in the absence of major surgery or bleeding is likely an important treatment goal.

Suicide, Self-harm, and Depression After Gastric Bypass Surgery: A Nationwide Cohort Study.

OBJECTIVE: The aim of this study was to examine risk of self-harm, hospitalization for depression and death by suicide after gastric bypass surgery (GBP). SUMMARY OF BACKGROUND DATA: Concerns regarding severe adverse psychiatric outcomes after GBP have been raised. METHODS: This nationwide, longitudinal, self-matched cohort encompassed 22,539 patients who underwent GBP during 2008 to 2012. They were identified through the Swedish National Patient Register, the Prescribed Drug Register, and the Causes of Death Register. Follow-up time was up to 2 years. Main outcome measures were hazard ratios (HRs) for post-surgery self-harm or hospitalization for depression in patients with presurgery self-harm and/or depression compared to patients without this exposure; and standardized mortality ratio (SMR) for suicide post-surgery. RESULTS: A diagnosis of self-harm in the 2 years preceding surgery was associated with an HR of 36.6 (95% confidence interval [CI] 25.5-52.4) for self-harm during the 2 years of follow up, compared to GBP patients who had no self-harm diagnosis before surgery. Patients with a diagnosis of depression preceding GBP surgery had an HR of 52.3 (95% CI 30.6-89.2) for hospitalization owing to depression after GBP, compared to GBP patients without a previous diagnosis of depression. The SMR for suicide after GBP was increased among females (n = 13), 4.50 (95% CI 2.50-7.50). The SMR among males (n = 4), was 1.71 (95% CI 0.54-4.12). CONCLUSIONS: The increased risk of post-surgery self-harm and hospitalization for depression is mainly attributable to patients who have a diagnosis of self-harm or depression before surgery. Raised awareness is needed to identify vulnerable patients with history of self-harm or depression, which may be in need of psychiatric support after GBP.