The change of epicardial adipose tissue characteristics and vulnerability for atrial fibrillation upon drastic weight loss.

BACKGROUND: Obesity increases the risk of atrial fibrillation (AF). We hypothesize that 'obese' epicardial adipose tissue (EAT) is, regardless of comorbidities, associated with markers of AF vulnerability. METHODS: Patients >40y of age undergoing bariatric surgery and using <2 antihypertensive drugs and no insulin were prospectively included. Study investigations were conducted before and 1y after surgery. Heart rhythm and p-wave duration were measured through ECGs and 7-d-holters. EAT-volume and attenuation were determined on non-enhanced CT scans. Serum markers were quantified by ELISA. RESULTS: Thirty-seven patients underwent surgery (age: 52.1 ± 5.9y; 27 women; no AF). Increased p-wave duration correlated with higher BMI, larger EAT volumes, and lower EAT attenuations (p < 0.05). Post-surgery, p-wave duration decreased from 109 ± 11 to 102 ± 11ms. Concurrently, EAT volume decreased from 132 ± 49 to 87 ± 52ml, BMI from 43.2 ± 5.2 to 28.9 ± 4.6kg/m2, and EAT attenuation increased from -76.1 ± 4.0 to -71.7 ± 4.4HU (p <0.001). Adiponectin increased from 8.7 ± 0.8 to 14.2 ± 1.0 µg/ml (p <0.001). However, decreased p-wave durations were not related to changed EAT characteristics, BMI or adiponectin. CONCLUSION: In this explorative study, longer p-wave durations related to higher BMIs, larger EAT volume, and lower EAT attenuations. P-wave duration and EAT volume decreased, and EAT attenuation increased upon drastic weightloss. However, there was no relation between decreased p-wave duration and changed BMI or EAT characteristics.

Cost-effectiveness and safety of continuous pulse oximetry for management of undiagnosed obstructive sleep apnea in bariatric surgery: a nationwide cohort study.

BACKGROUND: Undetected obstructive sleep apnea (OSA) is highly prevalent in patients undergoing bariatric surgery and increases perioperative risks. Screening for OSA using preoperative polygraphy (PG) with subsequent continuous positive airway pressure (CPAP) is costly and time-consuming. Postoperative continuous pulse oximetry (CPOX) is less invasive, and is hypothesized to be a safe and cost-effective alternative. OBJECTIVES: This nationwide multicenter prospective observational cohort study compared CPOX monitoring with OSA-screening using PG. SETTING: High-volume bariatric centers. METHODS: Patients were either postoperatively monitored using CPOX without preoperative OSA-screening, or underwent preoperative PG and CPAP treatment when OSA was diagnosed. Cohort placement was based on local hospital protocols. Cost-effectiveness was analyzed using quality adjusted life years (QALYs) and healthcare costs. Surgical outcomes were also analyzed. Propensity score matching was used in sensitivity analyses. RESULTS: A total of 1390 patients were included. QALYs were similar between groups at baseline and 1-year postoperatively. Postoperative complications, intensive care unit (ICU)-admissions and admissions, particularly OSA-related, did not differ between groups. Mean costs per patient/year in the CPOX group was €3094 versus €3680 in the PG group; mean difference €-586 (95% CI €-933-€-242). Following propensity score matching, 1090 of 1390 included patients remained, and similar findings for cost-effectiveness, complications, and ICU admissions were observed. CONCLUSION: CPOX monitoring without preoperative OSA-screening was not associated with higher complication or readmission rates compared to PG. CPOX resulted in lower costs from a healthcare perspective and can therefore be considered a cost-effective alternative to routine OSA-screening in patients undergoing bariatric surgery.

Safety of gastric bypass with same-day discharge: a propensity score-matched analysis of the Dutch Audit for treatment of Obesity.

BACKGROUND: Bariatric surgery with same-day discharge (SDD) is becoming increasingly common. Nevertheless, there is limited data available comparing gastric bypass patients with SDD to those with overnight hospitalization. OBJECTIVE: The aim of this study was to investigate the short-term outcomes of gastric bypass with SDD compared to overnight hospitalization in The Netherlands. SETTING: Retrospective database study with the use of the Dutch national registry. METHODS: Patients who underwent gastric bypass surgery in 2022 were included and propensity score matching was performed to compare SDD with patients discharged on postoperative days (POD) 1-4. The primary outcome was the occurrence of severe complications within 30 days postoperative. RESULTS: A total of 775 SDD patients were matched with 1550 patients discharged on POD 1-4. The occurrence of severe complications was .9% in both groups (P = 1.000), and there were no significant differences in reoperations or mortality. A significant difference was observed in the readmission rate, with 3.9% in the SDD group compared to 1.6% in the other group (P = .001). A proportionally small, yet statistically significant difference favored the control group regarding anastomotic leakages (.6% versus 0%, P = .004) and unspecified surgical complications (1.4% versus .5%, P = .028). CONCLUSION: Gastric bypass with SDD is safe, with no increased risk of short-term severe complications, reoperations, or mortality. However, SDD is associated with a higher 30-day readmission rate compared to patients who stay overnight in the hospital after surgery.

Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

Patient Satisfaction and Experience with Same-Day Discharge After Laparoscopic Roux-en-Y Gastric Bypass: A Mixed-Methods study.

INTRODUCTION: Same-day discharge (SDD) after laparoscopic Roux-en-Y gastric bypass (RYGB) is a safe and effective healthcare pathway. However, there is limited understanding of the patient perspective on SDD. The aim of this study was to explore patient satisfaction and experience with SDD after RYGB. METHODS: A mixed-methods study with a concurrent design was conducted in a Dutch teaching hospital, using questionnaires and interviews. Patients who underwent RYGB and were discharged on the day of the surgery completed four questionnaires of the BODY-Q (satisfaction with the surgeon, satisfaction with the medical team, satisfaction with the office staff, and satisfaction with information provision) ± 4 months postoperative. The results of the questionnaires were compared with pre-existing data from a cohort of patients who stayed overnight after surgery (i.e., control group). A subset of patients was individually interviewed for an in-depth understanding of the patient perspective on SDD. RESULTS: In the questionnaires, median scores for the control group (n = 158) versus the present group of patients (n = 51) were as follows: 92/100 vs. 92/100 (p = 0.331) for the surgeon, 100/100 vs. 92/100 (p = 0.775) for the medical team, 100/100 vs. 100/100 (p = 0.616) for the office staff, and 90/100 vs. 73/100 (p = 0.015) for information provision. Interviews with 14 patients revealed seven themes, describing high satisfaction, along with several points of interest. CONCLUSIONS: Patient satisfaction with SDD after RYGB is high, although information provision regarding the day of surgery could be improved. However, not every medically eligible patient might be suitable for this healthcare pathway, as responsibilities are shifted.

Feasibility of same-day discharge after laparoscopic sleeve gastrectomy in the Netherlands.

BACKGROUND: There is a trend towards laparoscopic sleeve gastrectomy (SG) with same-day discharge (SDD), as an efficient healthcare pathway to alleviate the burden on clinical capacity. This approach seems to be safe, if patients are carefully selected. In our bariatric center, a protocol for Roux-en-Y gastric bypass with SDD has already been successfully implemented. The aim of this study was to evaluate feasibility of applying the same SDD protocol for SG. METHODS: A single-center prospective feasibility study was conducted at a high-volume bariatric center. Low-risk patients who were scheduled for primary SG were included. Strict criteria were used for approval upon SDD. The primary outcome was the rate of successful SDD without readmission within 48 h. Secondary outcomes included short-term complications, emergency department visits, readmissions, and mortality. RESULTS: Fifty patients were included in the study, of whom 45 were successfully discharged on the same day of the surgery. Nausea and vomiting were the most common reasons for overnight hospitalization (three patients). One patient was readmitted within the first 48 h due to a mild complication related to bleeding, resulting in a success rate of 88% for SDD without readmission within 48 h. No severe complications or mortality were reported in the cohort. CONCLUSION: Our SDD protocol for SG has demonstrated feasibility, with a high success rate of SDD and no severe complications. Strict conditions should be met for the safe implementation of a SDD protocol, including careful patient selection and the establishment of a safety net to detect early complications.

Factors associated with decision regret after bariatric surgery.

It is assumed that the individuals who undergo bariatric surgery will experience significant improvements in their health and overall well-being. However, it is yet to be examined whether these individuals may also experience subsequent decision regret. The level of regret regarding the choice to undergo bariatric surgery was assessed 1 year after bariatric surgery using the Decision Regret Scale (DRS). Associations of regret with patient characteristics, complications, weight loss and quality of life (BODY-Q) were investigated using linear regression analyses. In total, 115 patients completed the DRS (92% underwent Roux-en-Y gastric bypass Roux-en-Y gastric bypass and 8% underwent sleeve gastrectomy (SG)). Two out of 115 patients indicated absolute regret about their decision to undergo bariatric surgery because of insufficient weight loss and complications. The median decision regret score was zero (range 0-80). Most patients experienced no decision regret (50.4%), followed by mild regret (34.8%) and moderate to strong regret (14.8%). Higher levels of regret were associated with having osteo-articular disorders, gastro-oesophageal reflux disease or a history of psychiatric disorders at baseline. Patients with mild regret demonstrated significantly more weight loss and better psychological function. Major surgical complications were not associated with increased decision regret. Only two out of 115 patients (1.7%) indicated absolute regret about their decision to undergo bariatric surgery, and 15% reported moderate-to-strong regret according to the results of the DRS. These findings should be considered when providing pre-operative counselling and could assist patients in their decision-making process.

Evaluation of Postoperative Care Protocol for Roux-en-Y Gastric Bypass Patients with Same-Day Discharge.

INTRODUCTION: Same-day discharge (SDD) after bariatric surgery is increasingly being performed and is safe with careful patient selection. However, detecting early complications during the first postoperative days can be challenging. We developed a postoperative care protocol for these patients and aimed to evaluate its effectiveness in detecting complications and monitoring patient recovery. METHODS: A single-center retrospective observational study was conducted with patients with who underwent Roux-en-Y Gastric Bypass (RYGB) with successful SDD. The study evaluated the effectiveness of the safety net that included simple remote monitoring with a pulsoximeter and thermometer, a phone consultation on postoperative day (POD) 1, and a physical consultation on POD 2-4. Furthermore, an analysis was performed on various factors including pain scores, painkiller usage, and incidences of nausea and vomiting on POD 1. RESULTS: In this study, 373 consecutive patients were included, of whom 19 (5.1%) were readmitted until POD 4. Among these, 12 patients (3.2%) reached out to the hospital themselves, while 7 (1.9%) were readmitted after phone or physical consultations. Ten of the readmitted patients had tachycardia. On POD 1, the mean numeric rating scale was 4 ± 2, and 96.6% of the patients used acetaminophen, 35.5% used naproxen, and 9.7% used oxynorm. Of the patients, 13.9% experienced nausea and 6.7% reported vomiting. CONCLUSION: A postoperative care protocol for SDD after RYGB, comprising simple remote monitoring along with a phone consultation on POD 1 and a physical checkup on POD 2-4, was effective in monitoring patient recovery and detecting all early complications.

Predictors of improved psychological function after bariatric surgery.

BACKGROUND: Negative psychological sequelae have been reported after bariatric surgery. It is unclear which factors affect psychological function in the first postoperative years. OBJECTIVE: Evaluation of significant predictors of improved psychological function following bariatric surgery by analyzing data from the BODY-Q questionnaire. SETTING: Multicenter prospective cohort in 3 centers located in The Netherlands and Denmark. METHODS: The BODY-Q questionnaire was used to assess 6 domains of health-related quality of life. The domain of interest, psychological function, consists of 10 questions from which a converted score of 0 (low) to 100 (high) can be calculated. Linear mixed models were used to analyze which patient characteristics were most predictive of the psychological function score. Secondary outcomes of interest were cross-sectional scores of psychological function and the impact of weight loss, and the effect of major short-term complications on psychological function. RESULTS: Data were analyzed from 836 patients who underwent bariatric surgery from 2015 to 2020. Patients with lower expectations concerning weight loss (<40% desired total weight loss), higher educational level, no history of psychiatric illness, and employment before bariatric surgery demonstrated the highest psychological function scores after bariatric surgery. At 1 and 2 years after bariatric surgery, more weight loss was associated with significantly higher psychological function scores. Experiencing a major short-term complication did not significantly impact psychological function. CONCLUSIONS: Several relevant predictors of improved postoperative psychological function have been identified. This knowledge can be used to enhance patient education preoperatively and identify patients at risk for poor psychological functioning postoperatively.

Feasibility of Same-Day Discharge After Laparoscopic Roux-en-Y Gastric Bypass in Patients with Well-Regulated Obstructive Sleep Apnea.

INTRODUCTION: Same-day discharge after bariatric surgery is increasingly being performed. In current practice, patients with only minor comorbidities are considered eligible for same-day discharge after laparoscopic Roux-en-Y gastric bypass (RYGB). Obstructive sleep apnea (OSA) is a common comorbidity in patients with morbid obesity, with a prevalence of around 70-80% among patients undergoing bariatric surgery. Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. We aimed to investigate whether same-day discharge after RYGB is feasible for patients with compliant use of CPAP. METHODS: In this single-center prospective feasibility study, patients were selected who were scheduled for RYGB and were adequately treated for OSA. Compliance on the use of CPAP had to be proved (> 4 h per night for 14 consecutive nights). There were strict criteria on approval upon same-day discharge. The primary outcome was the rate of successful same-day discharge. Secondary outcomes included short-term complications, emergency department presentations, readmissions, and mortality. RESULTS: Forty-nine patients underwent RYGB with intended same-day discharge, of whom 45 (92%) were successfully discharged. Three patients had an overnight stay because of divergent vital signs and one patient due to a delayed start of the surgery. Two patients (4%) were readmitted in the first 48 h postoperatively, both due to intraluminal bleeding which was managed conservatively (Clavien-Dindo 2). There were no severe complications in the first 48 h after surgery. CONCLUSION: Same-day discharge after RYGB can be considered feasible for selected patients with well-regulated OSA.

Same-Day Discharge After Laparoscopic Roux-en-Y Gastric Bypass: a Cohort of 500 Consecutive Patients.

INTRODUCTION: There is an increasing demand on hospital capacity worldwide due to the COVID-19 pandemic and local staff shortages. Novel care pathways have to be developed in order to keep bariatric and metabolic surgery maintainable. Same-day discharge (SDD) after laparoscopic Roux-en-Y gastric bypass (RYGB) is proved to be feasible and could potentially solve this challenge. The aim of this study was to investigate whether SDD after RYGB is safe for a selected group of patients. METHODS: In this single-center cohort study, low-risk patients were selected for primary RYGB with intended same-day discharge with remote monitoring. All patients were operated according to ERAS protocol. There were strict criteria on approval upon same-day discharge. It was demanded that patients should contact the hospital in case of any signs of complications. Primary outcome was the rate of successful same-day discharge without readmission within 48 h. Secondary outcomes included short-term complications, emergency department visits, readmissions, and mortality. RESULTS: Five hundred patients underwent RYGB with intended SDD, of whom 465 (93.0%) were successfully discharged. Twenty-one patients (4.5%) were readmitted in the first 48 h postoperatively. None of these patients had a severe bleeding. This results in a success rate of 88.8% of SDD without readmission within 48 h. CONCLUSIONS: Same-day discharge after RYGB is safe, provided that patients are carefully selected and strict discharge criteria are used. It is an effective care pathway to reduce the burden on hospital capacity.

A Decision Aid to Help Patients Make Informed Choices Between the Laparoscopic Gastric Bypass or Sleeve Gastrectomy.

PURPOSE: In the Netherlands, patients can often choose between the laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) as primary bariatric surgery. Yet, patients confronted with medical options may experience decisional conflict when their stakes are high and outcomes uncertain. This study aimed to assess if a decision aid helps patients make informed choices between two bariatric procedures by lowering the level of decisional conflict. MATERIALS AND METHODS: This study was a single-center comparative cohort of patients who accessed a web-based decision aid (intervention group) and those who did not use the decision aid (control group) to help choose between two bariatric procedures additional to the standard provided care. The primary outcome was the level of decisional conflict in these patients using the decisional conflict scale (DCS). Secondary outcomes were patient satisfaction with the provided information (BODY-QTM-satisfaction with information), preference of involvement in procedure selection, level of shared decision-making (SDM-Q-9 questionnaire), and patient knowledge. RESULTS: The level of decisional conflict assessed with the decisional conflict scale (DCS) showed a significantly lower mean total DCS of 25.5 ± 11.5 for the intervention group vs. 29.1 ± 12.4 in the control group (p = 0.022). Both groups did not significantly differ in satisfaction regarding provided information, involvement in the selection procedure, shared decision-making, and patient knowledge. CONCLUSION: The results suggest that the additional use of a decision aid significantly lowers the level of decisional conflict in patients awaiting bariatric surgery. However, the added value should be further investigated.

Using the BODY-Q to develop a prospective cohort of patients undergoing bariatric and body contouring surgery: A study protocol.

The BODY-Q is a patient-reported outcome measure designed to measure health-related quality of life, satisfaction with appearance and experience with healthcare in patients with obesity who undergo bariatric surgery and/or body contouring surgery after massive weight loss. The aim of this study is to collect long term PRO-data from patients living with obesity undergoing bariatric surgery, comparing patient undergoing or not undergoing body contouring surgery. This study will be a multicentre, prospective longitudinal cohort study with participation of three bariatric medical centres in the Netherlands. The BODY-Q will be used to measure the satisfaction with appearance and HRQL. Patients undergoing bariatric surgery, age >18 years and <65 years and who are able to read and understand Dutch can be included. All bariatric procedures are eligible for inclusion. Administration of the questionnaires will be done preoperatively for bariatric and body contouring surgery as well as at 3, 12, 24, 36, 48 and 60 months post-operatively. Patient-reported outcomes measurements are becoming more important with the shift to patient-centred healthcare. The collected longitudinal data can be helpful in determining the effectiveness and value of bariatric and body contouring surgery from the patient's perspective, and can contribute to patient tailored postoperative care.

The association between patient attendance to a perioperative group-based lifestyle program and weight loss after bariatric surgery.

BACKGROUND: To enable maximal and sustainable weight loss after bariatric surgery, bariatric lifestyle programs through multidisciplinary support are advised. OBJECTIVES: To assess the association between patient attendance to a perioperative group-based bariatric lifestyle program (GBLP) and weight loss up to 48 months postoperatively. SETTING: A multicenter retrospective cohort study in the Netherlands. METHODS: Patients who underwent primary laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) attended a GBLP in 2016 consisting of 18 sessions. A linear mixed model was used to assess the association between the patient attendance rate to the GBLP and total weight loss (%TWL). Independent predictors for the patient attendance rate and adequate %TWL were analyzed. RESULTS: A total of 3015 patients were included. Percentage of patients lost to follow-up was 5% at 1 year, 25% at 2 years, 34% at 3 years, and 42% at 4 years follow-up. Average TWL was 33% at 12 months after surgery, 33% at 24 months, 31% at 36 months, and 31% at 48 months. A small but significant adjusted positive association between the attendance rate and %TWL at 3 months until 36 months postoperatively was found (Beta between .03-.07), which disappeared at 48 months after surgery. Independent factors associated with a low attendance rate were younger age, male sex, and SG. Independent factors negatively associated with %TWL were male sex, SG, and diabetes. CONCLUSION: A higher patient attendance to GBLP sessions is associated with a small but significant increase in postoperative weight loss up to 3, but not 4 years after surgery.

Preoperative Assessment of Obstructive Sleep Apnea in Bariatric Patients Using Polysomnography or Polygraphy.

BACKGROUND: Preoperative assessment of obstructive sleep apnea (OSA) in patients scheduled for bariatric surgery can be performed by in-laboratory polysomnography (PSG) or by portable polygraphy (PP) at home. We aimed to evaluate the association between PSG/PP, OSA diagnosis, and implementation of continuous positive airway pressure (CPAP) therapy. METHODS: All patients who underwent bariatric surgery from 2015 to 2017 were retrospectively reviewed. Patients underwent preoperative PSG or PP, based on prevailing protocols or at the physician's discretion. Logistic regression analyses were performed to determine predictors of CPAP implementation. OSA-related postoperative complications were analyzed in both groups. RESULTS: During the study period, 1464 patients were included. OSA was diagnosed in 79% of 271 patients undergoing PSG, compared to 64% of 1193 patients undergoing PP (p < 0.001), with median apnea-hypopnea index (AHI) of 15.8 and 7.7, respectively. CPAP treatment was initiated in 52% and 27% of patients, respectively, p < 0.001. Predictors (with adjusted odds ratio) in multivariate regression analysis for CPAP implementation were as follows: male gender (5.15), BMI ≥ 50 (3.85), PSG test (2.74), hypertension (2.38), and age ≥ 50 (1.87). OSA-related complications did not differ between groups (p = 0.277). CONCLUSION: Both PSG and PP are feasible options for preoperative OSA assessment in bariatric patients. When PP is performed, some underdiagnosis may occur as cases of mild OSA may be missed. However, clinically relevant OSA is detected by both diagnostic tools. No difference in OSA-related complications was found. PP is a safe, less invasive option and can be considered as a suitable measure for OSA assessment in this population.

Becoming pregnant within the first year after bariatric surgery adversely affects postoperative weight loss.

BACKGROUND: Approximately 80% of the patients undergoing bariatric surgery are female, with half of them undergoing surgery during their reproductive years. Most guidelines recommend that women wait at least 12 months after surgery before becoming pregnant. No previous studies have investigated whether becoming pregnant in the first or second year after surgery affects weight loss. OBJECTIVES: The aim of this study was to assess whether pregnancy within the first or second year after bariatric surgery affects weight loss up to 5 years after surgery. SETTING: A single institution. METHODS: This study is a retrospective study of women who underwent primary bariatric surgery between 2012 and 2016. Weight outcomes were measured until 5 years after surgery. A linear mixed model was used to assess the effect of the time between surgery and conception in groups on the basis of percentage total weight loss. RESULTS: A total of 55 patients undergoing a primary bariatric procedure were included. Forty-seven women underwent a laparoscopic Roux-en-Y gastric bypass (85.5%), and 8 underwent a sleeve gastrectomy (14.5%). The median time between surgery and estimated conception was 22 months (range: 0-51 months). Women who became pregnant between 12 and 24 months after bariatric surgery (n = 18) and women who became pregnant after 24 months (n = 24) had significantly more weight (ß = 3.95, P = .020, and ß = 4.09, P =.024, respectively) than women who became pregnant within 12 months after bariatric surgery (n = 12). CONCLUSION: Our results suggest that pregnancy within 12 months after bariatric surgery negatively affects the long-term weight loss after bariatric surgery.

Is the RAND-36 an Adequate Patient-reported Outcome Measure to Assess Health-related Quality of Life in Patients Undergoing Bariatric Surgery?

PURPOSE: The RAND-36 is the most frequently used patient-reported outcome measure (PROM) to evaluate health-related quality of life (HRQoL) in bariatric surgery. However, the RAND-36 has never been adequately validated in bariatric surgery. The purpose of this study was to validate the RAND-36 in Dutch patients undergoing bariatric surgery. MATERIAL AND METHODS: To validate the RAND-36, the following measurement properties were assessed in bariatric surgery patients: validity (the degree to which the RAND-36 measures what it purports to measure (HRQoL)), reliability (the extent to which the scores of the RAND-36 are the same for repeated measurement for patients who have not changed in HRQoL), responsiveness (the ability of the RAND-36 to detect changes in HRQoL over time). RESULTS: Two thousand one hundred thirty-seven patients were included. Validity was not adequate due to the irrelevance of some items and response options, the lack of items relevant to patients undergoing bariatric surgery, and the RAND-36 did not actually measure what it was intended to measure in this study (HRQoL in bariatric surgery patients). Reliability was insufficient for the majority of the scales (the scores of patients who had not changed in HRQoL were different when the RAND was completed a second time (intraclass correlation coefficient (ICC) values 0.10-0.69)). Responsiveness was insufficient. CONCLUSION: The RAND-36 was not supported by sufficient validation evidence in patients undergoing bariatric surgery, which means that the RAND-36 does not adequately measure HRQoL in this patient population. Future research studies should use PROMs that are specifically designed for assessing HRQoL in patients undergoing bariatric surgery.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial.

BACKGROUND: Rapid weight loss is a major risk factor for the formation of cholesterol gallstones. Consequently, patients with morbid obesity undergoing bariatric surgery frequently develop symptomatic gallstone disease. This trial assessed the efficacy of ursodeoxycholic acid versus placebo for the prevention of symptomatic gallstone disease after bariatric surgery. METHODS: This multicentre, double-blind, randomised, placebo-controlled superiority trial enrolled patients with an intact gallbladder scheduled for laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy in three hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module to receive 900 mg ursodeoxycholic acid daily for 6 months or matched placebo. Randomisation was stratified by the presence of asymptomatic gallstones at baseline and type of surgery. Patients, clinicians, and study staff were masked to treatment allocation. The primary endpoint was symptomatic gallstone disease within 24 months, assessed in the modified intention-to-treat population (all randomly assigned eligible patients with any post-randomisation measurement). Prespecified subgroup analyses were done based on the stratification groups. Safety was assessed in all patients who took at least one dose of the study drug. This trial is registered with the Netherlands Trial Register, NL5954. FINDINGS: Between Jan 11, 2017, and Oct 22, 2018, 985 patients were randomly assigned to receive either ursodeoxycholic acid (n=492) or placebo (n=493). 967 patients were included in the modified intention-to-treat population, of whom 959 had data available for primary endpoint assessment. 189 (20%) patients had asymptomatic gallstones at baseline and 78 (8%) received a sleeve gastrectomy. Symptomatic gallstone disease occurred in 31 (6·5%) of 475 patients in the ursodeoxycholic acid group and in 47 (9·7%) of 484 patients in the placebo group (relative risk 0·67, 95% CI 0·43-1·04, p=0·071). Logistic regression showed a significant interaction between ursodeoxycholic acid and the presence of asymptomatic gallstones at baseline (p=0·046), with an effect of ursodeoxycholic acid in patients without (0·47, 0·27-0·84, p=0·0081), and no effect in patients with asymptomatic gallstones at baseline (1·22, 0·61-2·47, p=0·57). The effect was stronger in patients without gallstones at baseline undergoing RYGB (0·37, 0·20-0·71, p=0·0016), whereas the subgroup of patients undergoing sleeve gastrectomy was too small to draw clear conclusions. Adverse events were rare. In the ursodeoxycholic acid group, diarrhoea occurred in four (0·9%) of 444 patients and skin rash in two (0·5%) patients. In the placebo group, diarrhoea occurred in two (0·4%) of 453 patients and skin rash in two (0·4%) patients. The total number of serious adverse events did not significantly differ between the trial groups (75 [17%] in 444 patients in the ursodeoxycholic acid group and 102 [23%] in 453 patients in the placebo group). The most common serious adverse events were abdominal pain and internal hernia. No serious adverse event was attributed to the study drug. INTERPRETATION: Ursodeoxycholic acid prophylaxis did not significantly reduce the occurrence of symptomatic gallstone disease in all patients after bariatric surgery. In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease compared with placebo. Further research is needed to assess the efficacy of ursodeoxycholic acid after sleeve gastrectomy. FUNDING: The Netherlands Organization for Health Research and Development, Zambon Netherlands BV, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism.

Comparing a Short Biliopancreatic Limb to a Long Biliopancreatic Limb in Patients with a Roux-en-Y Gastric Bypass with 4 Years Follow-up.

INTRODUCTION: In order to design the most effective weight loss procedure, the ideal biliopancreatic limb (BPL) and alimentary limb (AL) length in Roux-en-Y gastric bypass (RYGB) have been discussed extensively. Yet, no consensus has been reached. The aim of this study was to compare weight loss after a short and long BPL in patients who underwent a RYGB with a minimum of 4 years follow-up. METHODS: This retrospective cohort study consisted of 574 patients who underwent a primary RYGB procedure between March 2015 and January 2017. Patients were divided in two groups based on the surgical procedure performed: a short BPL group (BPL of 50 cm with an AL of 150 cm) and long BPL group (BPL of 150 cm with an AL of 75 cm). The percentage total weight loss (%TWL) between groups was compared up to 4 years after surgery. Secondary outcomes were 30-day postoperative complications and health-related quality of life (RAND-36). RESULTS: The short BPL group consisted of 286 patient and the long BPL group of 288 patients. Follow-up rates of both groups at the first, second, third, and fourth year after surgery were comparable. The long BPL group showed significantly more %TWL compared to the short BP limb group starting at 6 months (p = 0.004) until 4 years after surgery (p < 0.001). Thirty-day complications and health-related quality of life did not differ. CONCLUSION: The results showed significantly more %TWL in patients receiving a long BPL compared to the short BPL up to 4 years after surgery.

Impact of the COVID-19 pandemic on incidence and severity of acute appendicitis: a comparison between 2019 and 2020.

BACKGROUND: During the COVID-19 pandemic, a decrease in the number of patients presenting with acute appendicitis was observed. It is unclear whether this caused a shift towards more complicated cases of acute appendicitis. We compared a cohort of patients diagnosed with acute appendicitis during the 2020 COVID-19 pandemic with a 2019 control cohort. METHODS: We retrospectively included consecutive adult patients in 21 hospitals presenting with acute appendicitis in a COVID-19 pandemic cohort (March 15 - April 30, 2020) and a control cohort (March 15 - April 30, 2019). Primary outcome was the proportion of complicated appendicitis. Secondary outcomes included prehospital delay, appendicitis severity, and postoperative complication rates. RESULTS: The COVID-19 pandemic cohort comprised 607 patients vs. 642 patients in the control cohort. During the COVID-19 pandemic, a higher proportion of complicated appendicitis was seen (46.9% vs. 38.5%; p = 0.003). More patients had symptoms exceeding 24 h (61.1% vs. 56.2%, respectively, p = 0.048). After correction for prehospital delay, presentation during the first wave of the COVID-19 pandemic was still associated with a higher rate of complicated appendicitis. Patients presenting > 24 h after onset of symptoms during the COVID-19 pandemic were older (median 45 vs. 37 years; p = 0.001) and had more postoperative complications (15.3% vs. 6.7%; p = 0.002). CONCLUSIONS: Although the incidence of acute appendicitis was slightly lower during the first wave of the 2020 COVID-19 pandemic, more patients presented with a delay and with complicated appendicitis than in a corresponding period in 2019. Spontaneous resolution of mild appendicitis may have contributed to the increased proportion of patients with complicated appendicitis. Late presenting patients were older and experienced more postoperative complications compared to the control cohort.