Development of the International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC) Grade-Based Guidelines on the Surgical Treatment of Obesity Using Multimodal Strategies: Design and Methodological Aspects.

Background: The prevalence of obesity is already a worldwide health concern. The development of straightforward guidelines regarding the whole available armamentarium (i.e., medical, endoscopic, and surgical interventions in conjunction with a guidance program) is paramount to offering the best multimodal approach to patients with obesity. Methods: The International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC) identified a panel of experts to develop the present guidelines. The panel formulated a series of clinical questions (based on the patient, intervention, comparison, and outcome conceptual framework), which have been voted on and approved. A GRADE methodology will be applied to assess the quality of evidence and formulate recommendations employed to minimize selection and information biases. This approach aims to enhance the reliability and validity of recommendations, promoting greater adherence to the best available evidence. Results: These guidelines are intended for adult patients with a body mass index (BMI) ≥ 30 kg/m2 who are candidates for metabolic bariatric surgery (MBS). The expert panel responsible for developing these guidelines comprised 25 panelists (92% were bariatric surgeons) and 3 evidence reviewers, with an average age of 50.1 ± 10.2 years. The panel focused on 3 key questions regarding the combined use of structured lifestyle interventions, approved obesity management medications, and endoscopic weight loss procedures with MBS. Conclusions: The complexity of obesity as a chronic disease requires a comprehensive knowledge of all the available and feasible therapeutic options. The IFSO-EC society felt the urgent need to develop methodologically valid guidelines to give a full picture and awareness of the possible surgical and non-surgical therapeutic strategies employed with a multimodal approach.

An observational cohort of patients with colorectal peritoneal metastases or pseudomyxoma peritonei treated with CRS-HIPEC: Development and first results of the Dutch CRS-HIPEC quality registry.

INTRODUCTION: To improve care for patients with colorectal peritoneal metastases (CRC-PM) or pseudomyxoma peritonei (PMP), the Dutch CRS-HIPEC quality registry was initiated in 2019. The aims are to describe the development and content of this registry and to give insight into the data collected during the first years. MATERIALS AND METHODS: The registry is an observational cohort in the Netherlands. All patients with CRC-PM or PMP who intend to undergo cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) from 6 hospitals are included. Clinical data and outcomes (including hospital variation) were analyzed. RESULTS: In 2019-2022, 889 patients were included in the CRS-HIPEC quality registry: 749 (84 %) with CRC-PM and 140 (16 %) with PMP. Peritoneal metastases were diagnosed synchronously in 51 % of CRC-PM patients and in 94 % of PMP patients. In patients undergoing complete CRS, the median peritoneal cancer index was 8 (IQR 4-13) for CRC-PM and 15 (IQR 6-26) for PMP. Complete cytoreduction was achieved in 639 CRC-PM patients (97 %) and 108 PMP patients (82 %). HIPEC was mainly performed with mitomycin C (CRC-PM: 94 %, PMP: 92 %). Major postoperative complications (Clavien-Dindo grade ≥3) occurred in 148 CRC-PM patients (22 %) and 30 PMP patients (23 %) with 90-day mortality rates of 2 %. In CRC-PM, differences between hospitals were observed regarding proportions of diagnostic laparoscopies/laparotomies, (neo)adjuvant treatment, ostomy formations and re-admissions. CONCLUSION: The CRS-HIPEC quality registry provides insight into the outcomes of CRS-HIPEC and enables clinical auditing and observational cohort studies aiming to improve treatment outcomes for patients with CRC-PM and PMP.

Adding Evidence to an Evidence-Based Classification for Recurrent Weight Gain after Bariatric and Metabolic Surgery from a Norwegian National Registry.

BACKGROUND: In 2023, the first evidence-based classification for recurrent weight gain (RWG) after metabolic and bariatric surgery was introduced. It uses early and late follow-up weight loss benchmarks based on standard deviations (SD) of percentage total weight loss(%TWL) results from the large Dutch Audit for Treatment of Obesity (DATO) registry (n > 18,000). We aimed to validate this classification and confirm its clinical relevance with an external cohort. METHODS: The DATO-based classification defines all RWG as grade 1, as long as weight-loss does not drop below DATO's late-follow-up minus one SD benchmark (20%TWL). Grade 3 represents clear outliers whose RWG evolves below DATO's late follow-up minus two SD benchmark (10%TWL), with grade 2 in-between. Grades 2a/3a represent initial suboptimal clinical response, with nadir %TWL never exceeding DATO's early-follow-up minus one SD benchmark (25%TWL). Grades 2b/3b represent late clinical deterioration from nadir weight loss ≥ 25%TWL. We compared baseline characteristics, SD based benchmarks, RWG and comorbidities from the Scandinavian Obesity Surgery Registry Norway (SOReg-N) with these DATO-derived grades. RESULTS: The SOReg-N population (n = 3064) was comparable at baseline, with more sleeve gastrectomies (54% versus DATO 22.5%). The SD benchmarks were at early follow-up minus one SD 25.8%TWL, at 5 years minus one SD/minus two-SD 17.2%TWL/7.0%TWL (DATO 25%TWL/20%TWL/10%TWL). Percentage of patients and amount of RWG were similar to DATO. In line with DATO, comorbidities were predominant in grades 2a/3a, with least improvement in grade 3a. Also, grade 3b showed more favorable characteristics at baseline. CONCLUSION: The SOReg-N cohort confirmed the weight-loss benchmarks defining the DATO-derived grades, the distribution of patients and their RWG across the grades, and correlations between grades and comorbidities. Male gender, older age and comorbidities were predominant among patients with initial suboptimal clinical response (RWG grades 2a/3a), but not for late clinical deterioration (RWG grades 2b/3b). This classification can be used for populations with diverse weight loss trajectories and offers an evidence-based guide for clinical decision-making and standardization.

Patient-reported outcomes during first-line palliative systemic therapy alternated with pressurized intraperitoneal aerosol chemotherapy for unresectable colorectal peritoneal metastases: a single-arm phase II trial (CRC-PIPAC-II).

BACKGROUND: The CRC-PIPAC-II study prospectively assessed bidirectional therapy (BT) consisting of first-line palliative systemic therapy and electrostatic precipitation oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (ePIPAC-OX) in patients with unresectable colorectal peritoneal metastases (CPM). This study describes the exploration of patient-reported outcomes (PROs). METHODS: In this phase II trial, 20 patients with isolated CPM were treated with up to three cycles of BT, each cycle consisting of two to three courses of systemic therapy, followed by ePIPAC-OX (92 mg/m2). Patients were asked to complete the EuroQoL EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-CR29 questionnaires at baseline, during the first cycle of BT, and one and four weeks after each consecutive BT cycle. PRO scores were calculated and compared between baseline and each subsequent time point using linear-mixed modeling (LMM). PROs were categorized into symptom scales and function scales. Symptom scales ranged from 0 to 100, with 100 representing the maximum symptom load. Function scales ranged from 0 to 100, with 100 representing optimal functioning. RESULTS: Twenty patients underwent a total of 52 cycles of bidirectional therapy. Most PROs (29 of 37, 78%) were not significantly affected during trial treatment. In total, only eight PROs (22%) were significantly affected during trial treatment: Six PROs (index value, global health status, emotional functioning, C30, appetite, and insomnia) showed transient improvement at different time points. Two PROs transiently deteriorated: pain initially improved during the first BT cycle [- 16, p < 0.001] yet worsened temporarily one week after the first two BT cycles (+ 20, p < 0.001; + 17, p = 0.004; respectively). Abdominal pain worsened temporarily one week after the first BT cycle (+ 16, p = 0.004), before improving again four weeks after treatment ended (- 10, p = 0.004). All significant effects on Pros were clinically significant and all deteriorations in PROs were of temporary nature. DISCUSSION: Patients undergoing BT for unresectable CPM had significant, but reversible alterations in several PROs. Most affected PROs concerned improvements and only two PROs showed deteriorations. Both deteriorated PROs returned to baseline after trial treatment and were of a temporary nature. These outcomes help to design future studies on the role of ePIPAC in the palliative setting.

The Impact of Longer Biliopancreatic Limb Length on Weight Loss and Comorbidity Improvement at 5 Years After Primary Roux-en-Y Gastric Bypass Surgery: A Population-Based Matched Cohort Study.

INTRODUCTION: Different limb lengths are used in Roux-en-Y gastric bypass (RYGB) surgery, as there is no consensus which limb length strategy has the best outcomes. The biliopancreatic limb (BPL) is thought to play an important role in achieving weight loss and associated comorbidity resolution. The objective of this study was to assess the impact of a longer BPL on weight loss and comorbidity improvement at 5 years after primary RYGB. METHODS: All patients aged ≥ 18 years undergoing primary RYGB between 2014-2017 with registered follow-up 5 years after surgery were included. Long BPL was defined as BPL ≥ 100 cm and short BPL as BPL < 100 cm. The primary outcome was achieving at least 25% total weight loss (TWL) at 5 years. Secondary outcomes included absolute %TWL and improvement of comorbidities. A propensity score matched logistic and linear regression was used to estimate the difference in outcomes between patients with long and short BPL. RESULTS: At 5 years, long BPL had higher odds to achieve ≥ 25% TWL (odds ratio (OR) 1.19, 95% confidence interval (CI) [1.01 - 1.41]) and was associated with 1.26% higher absolute TWL (ß = 1.26, 95% CI [0.53 - 1.99]). Furthermore, long BPL was more likely to result in improved diabetes mellitus (OR = 2.17, 95% CI [1.31 - 3.60]) and hypertension (OR = 1.45, 95% CI [1.06 - 1.99]). CONCLUSION: Patients undergoing RYGB with longer BPL achieved higher weight loss and were more likely to achieve improvement of comorbidities at 5 years.

Optimizing Hospital Performance Evaluation in Total Weight Loss Outcomes After Bariatric Surgery: A Retrospective Analysis to Guide Further Improvement in Dutch Hospitals.

INTRODUCTION: Bariatric surgery aims for optimal patient outcomes, often evaluated through the percentage total weight loss (%TWL). Quality registries employ funnel plots for outcome comparisons between hospitals. However, funnel plots are traditionally used for dichotomous outcomes, requiring %TWL to be dichotomized, potentially limiting feedback quality. This study evaluates whether a funnel plot around the median %TWL has better discriminatory performance than binary funnel plots for achieving at least 20% and 25% TWL. METHODS: All hospitals performing bariatric surgery were included from the Dutch Audit for Treatment of Obesity. A funnel plot around the median was constructed using 5-year %TWL data. Hospitals positioned above the 95% control limit were colored green and those below red. The same hospitals were plotted in the binary funnel plots for 20% and 25% TWL and colored according to their performance in the funnel plot around the median. We explored the hospital's procedural mix in relation to %TWL performance as possible explanatory factors. RESULTS: The median-based funnel plot identified four underperforming and four outperforming hospitals, while only one underperforming and no outperforming hospitals were found with the binary funnel plot for 20% TWL. The 25% TWL binary funnel plot identified two underperforming and three outperforming hospitals. The proportion of sleeve gastrectomies performed per hospital may explain part of these results as it was negatively associated with median %TWL (ß = - 0.09, 95% confidence interval [- 0.13 to - 0.04]). CONCLUSION: The funnel plot around the median discriminated better between hospitals with significantly worse and better performance than funnel plots for dichotomized %TWL outcomes.

First-line palliative systemic therapy alternated with oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy for unresectable colorectal peritoneal metastases: A single-arm phase II trial (CRC-PIPAC-II).

BACKGROUND: Palliative systemic therapy alternated with electrostatic precipitation oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (ePIPAC) has never been prospectively investigated in patients with unresectable colorectal peritoneal metastases (CPM). The CRC-PIPAC-II study aimed to assess safety, feasibility and efficacy of such bidirectional therapy. METHODS: This two-center, single-arm, phase II trial enrolled chemotherapy-naïve patients to undergo three treatment cycles, consisting of systemic therapy (CAPOX, FOLFOX, FOLFIRI, or FOLFOXIRI, all with bevacizumab) and oxaliplatin-based ePIPAC (92 mg/m2) with intravenous leucovorin (20 mg/m2) and 5-fluorouracil (400 mg/m2). Primary outcome were major treatment-related adverse events. Secondary outcomes included minor events, tumor response, progression-free survival (PFS) and overall survival (OS). RESULTS: Twenty patients completed 52 treatment cycles. Fifteen major events occurred in 7 patients (35 %): 5 events (33 %) related to systemic therapy; 5 (33 %) related to ePIPAC; and 5 (33 %) were biochemical events. No treatment-related deaths occurred. All patients experienced minor events, mostly abdominal pain, nausea and peripheral sensory neuropathy. After treatment, radiological, pathological, cytological, and biochemical response was observed in 0 %, 88 %, 38 %, and 31 % of patients respectively. Curative surgery was achieved in one patient. Median PFS was 10.0 months (95 % confidence interval [CI] 8.0-13.0) and median OS was 17.5 months (95 % CI 13.0-not reached). CONCLUSIONS: Combining palliative systemic therapy with oxaliplatin-based ePIPAC in patients with unresectable CPM was feasible and showed an acceptable safety profile. Treatment-induced response and survival are promising, yet further research is required to determine the additional value of ePIPAC to systemic therapy.

The impact of duration and severity of obesity exposure on cardiometabolic health.

PURPOSE: Duration and severity of exposure to excess adipose tissue are important risk factors for complications, but are generally not examined in conjunction. We developed a metric considering both factors to examine the relationship between obesity-related complications and parameters of cardiometabolic health in patients undergoing a metabolic bariatric procedure (MBS). MATERIALS & METHODS: Data from patients screened for primary MBS between 2017 and 2021 were analyzed. The Obesity Exposure score (OBES), based on self-reported years of life with a BMI ≥ 25 kg/m2, was calculated with increased weighting applied for higher BMI categories. Multivariate logistic regression analysis was performed, adjusting for multiple potential confounders. RESULTS: In total, 2441 patients were included (76% female, age 42.1 ± 11.9 years, BMI 42.0 ± 4.9 kg/m2). OBES was positively related to myocardial infarction, atrial fibrillation and renal function loss (per 10 OBES-units: OR 1.31, 95%CI [1.11-1.52], p = 0.002; OR 1.23, 95% CI [1.06-1.44], p = 0.008; and OR 1.26, 95% CI [1.04-1.51], p = 0.02). OBES was negatively associated with obstructive sleep apnea syndrome (OSAS) (OR 0.90, 95% CI [0.83-0.98], p = 0.02). In patients without obesity-related complications, OBES was related to lower HbA1c and higher HDL-cholesterol levels (ß -0.5 95% CI [-0.08-.0.02] p < 0.001 and ß 0.02 [0.00-0.04] p = 0.01). CONCLUSION: OBES was related to myocardial infarction, atrial fibrillation and renal function loss in patients applying for MBS. OBES was negatively related to OSAS, possibly because undiagnosed years were not taken into account. In the absence of obesity-related complications, OBES was not related to metabolic blood markers. Our data may aid in improving perioperative risk assessments.

Towards Equal Access to Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy and Survival in Patients with Isolated Colorectal Peritoneal Metastases: A Nationwide Population-Based Study.

BACKGROUND: Before 2016, patients with isolated synchronous colorectal peritoneal metastases (PMCRC) diagnosed in expert centers had a higher odds of undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) and better overall survival (OS) than those diagnosed in referring centers. Nationwide efforts were initiated to increase awareness and improve referral networks. METHODS: This nationwide study aimed to evaluate whether the between-center differences in odds of undergoing CRS-HIPEC and OS have reduced since these national efforts were initiated. All patients with isolated synchronous PMCRC diagnosed between 2009 and 2021 were identified from the Netherlands Cancer Registry. Associations between hospital of diagnosis and the odds of undergoing CRS-HIPEC, as well as OS, were assessed using multilevel multivariable regression analyses for two periods (2009-2015 and 2016-2021). RESULTS: In total, 3948 patients were included. The percentage of patients undergoing CRS-HIPEC increased from 17.2% in 2009-2015 (25.4% in expert centers, 16.5% in referring centers), to 23.4% in 2016-2021 (30.2% in expert centers, 22.6% in referring centers). In 2009-2015, compared with diagnosis in a referring center, diagnosis in a HIPEC center showed a higher odds of undergoing CRS-HIPEC (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.02-2.67) and better survival (hazard ratio [HR] 0.80, 95% CI 0.66-0.96). In 2016-2021, there were no differences in the odds of undergoing CRS-HIPEC between patients diagnosed in HIPEC centers versus referring centers (OR 1.27, 95% CI 0.76-2.13) and survival (HR 1.00, 95% CI 0.76-1.32). CONCLUSION: Previously observed differences in odds of undergoing CRS-HIPEC were no longer present. Increased awareness and the harmonization of treatment for PMCRC may have contributed to equal access to care and a similar chance of survival at a national level.

Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass).

Background: Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. Methods: This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was -13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900. Findings: 628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%-63%] after sleeve gastrectomy and 67.1% [95% CI, 63%-71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, -12.5% to -4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%-24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%-27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, -5.2% to -1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered. Interpretation: In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups. Funding: Not applicable.

Understanding social dynamics and patient experience in out of hospital care: validation of a co-responsibility questionnaire (CoReCare).

Patient experiences are commonly assessed through patient reported experience measures (PREMs). Ambulatory care models extend traditional care into the patients' home, meaning that a triangle of health care professionals, patients, and their families need to be considered when assessing the remote care experience. These intertwined responsibilities are described by co-responsibility. Currently, PREMs don't reflect how elements to remote care impact this remote care experience. Therefore, this study aimed to develop a questionnaire assessing perceived patient-partner co-responsibility as a PREM in remote care. A 30-item questionnaire was assessed among 1000 individuals aged between 18 and 65 years that tried to lose weight with a partner, friend or family member supporting them. Pairwise item correlations, Exploratory Factor Analysis, and Cronbach's alpha were used for validation. 29-items were identified to reflect co-responsibility across 6 factors: empowerment and support, relational aspects, lack of sympathy, co-participation, accepting help and awareness. Cronbach's alpha ranged between 0.66 and 0.93, showing good internal consistency. We present a validated CoReCare Questionnaire to understand the impact of social dynamics on achieving desired health outcomes in a remote care setting. The CoReCare Questionnaire extends current PREMs when aiming to assess and improve the patient experience of a care episode outside of the hospital.

Surgical Aspects of Sleeve Gastrectomy Are Related to Weight Loss and Gastro-esophageal Reflux Symptoms.

INTRODUCTION: A large variation in outcome has been reported after sleeve gastrectomy (SG) across countries and institutions. We aimed to evaluate the effect of surgical technique on total weight loss (TWL) and gastro-esophageal reflux disease (GERD). METHODS: Observational cohort study based on data from the national registries for bariatric surgery in the Netherlands, Norway, and Sweden. A retrospective analysis of prospectively obtained data from surgeries during 2015-2017 was performed based on 2-year follow-up. GERD was defined as continuous use of acid-reducing medication. The relationship between TWL, de novo GERD and operation technical variables were analyzed with regression methods. RESULTS: A total of 5927 patients were included. The average TWL was 25.6% in Sweden, 28.6% in the Netherlands, and 30.6% in Norway (p < 0.001 pairwise). Bougie size, distance from the resection line to the pylorus and the angle of His differed between hospitals. A minimized sleeve increased the expected total weight loss by 5-10 percentage points. Reducing the distance to the angle of His from 3 to just above 0 cm increased the risk of de novo GERD five-fold (from 3.5 to 17.8%). CONCLUSION: Smaller bougie size, a shorter distance to pylorus and to the angle of His were all associated with greater weight loss, whereas a shorter distance to angle of His was associated with more de novo reflux.

Intraperitoneal irinotecan with concomitant FOLFOX and bevacizumab for patients with unresectable colorectal peritoneal metastases: protocol of the multicentre, open-label, phase II, INTERACT-II trial.

INTRODUCTION: The peritoneum is the second most affected organ for the dissemination of colorectal cancer (CRC). Patients with colorectal peritoneal metastases (CPM) face a poor prognosis, despite the majority of patients being treated with palliative systemic therapy. The efficacy of palliative systemic therapy is limited due to the plasma-peritoneum barrier. The poor prognosis of unresectable CPM patients has resulted in the development of new treatment strategies where systemic therapy is combined with local, intraperitoneal chemotherapy. In the recently published phase I study, the maximum tolerated dose and thus the recommended phase II dose of intraperitoneal irinotecan was investigated and determined to be 75 mg. In the present study, the overall survival after treatment with 75 mg irinotecan with concomitant mFOLFOX4 and bevacizumab will be investigated. MATERIALS AND METHODS: In this single-arm phase II study in two Dutch tertiary referral centres, 85 patients are enrolled. Eligibility criteria are an adequate performance status and organ function, histologically confirmed microsatellite stable and unresectable CPM, no previous palliative therapy for CRC, no systemic therapy<6 months for CRC prior to enrolment and no previous cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS and HIPEC). Patients will undergo a diagnostic laparoscopy as standard work-up for CPM and if the peritoneal disease is considered unresectable (eg, Peritoneal Cancer Index (PCI)>20, too extensive small bowel involvement), a peritoneal access port and a port-a-cath are placed for administration of intraperitoneal and intravenous chemotherapy, respectively. Patients may undergo up to 12 cycles of study treatment. Each cycle consists of intravenous mFOLFOX4 with bevacizumab and concomitant intraperitoneal irinotecan (75 mg), which is repeated every 2 weeks, with a maximum of 12 cycles. Modified FOLFOX-4 regimen consists of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2 bolus on day 1 followed by 1600 mg/m2 5-FU as a 46 hours infusion. Study treatment ends after the 12th cycle, or earlier in case of disease progression or unacceptable toxicity. The primary outcome is overall survival and key secondary outcomes are progression-free survival, safety (measured by the amount of grade ≥3 adverse events (Common Terminology Criteria for Adverse Events V.5.0)), patient-reported outcomes and pharmacokinetics of irinotecan. It is hypothesised that the trial treatment will lead to a 4 month increase in overall survival; from a median of 12.2 to 16.2 months. ETHICS AND DISSEMINATION: This study is approved by the Dutch Authority (CCMO, the Hague, the Netherlands), by a central medical ethics committee (MEC-U, Nieuwegein, the Netherlands) and by the institutional research boards of both research centres. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals. TRIAL REGISTRATION NUMBER: NCT06003998.

Patient's Preference for Same-Day Discharge or Hospitalization After Bariatric Surgery.

PURPOSE: Enhanced Recovery After Bariatric Surgery protocols have proven to be effective in reducing complication rates and length of stay. Guidelines do not include a recommendation on the length of hospital stay whereas same-day discharge is currently widely investigated on safety and feasibility. However, none of these studies takes patient preferences into account. The study aimed to reveal the patient's preference for outpatient surgery (OS) in patients who underwent primary bariatric surgery. MATERIALS AND METHODS: A single-center preference-based randomized trial was performed between March and December of 2021. Adult patients planned for primary bariatric surgery were able to choose their care pathway, either OS with remote heart and respiratory rate monitoring by a wearable data logger or standard care with at least one-night hospitalization. RESULTS: Out of the 202 patients, nearly everyone (98.5%) had a preference. Of 199 patients, 99 (49.7%) chose inpatient surgery. Of the 100 with a preference for OS, 23 stayed in the hospital due to medical reasons and 12 patients changed their preference. Based on both initial preference and changed preference, there were no differences between sex, age, body mass index, and co-morbidities such as diabetes mellitus, hypertension, and atrial fibrillation, nor in the use of anticoagulants or type of surgery. CONCLUSION: Patients seemed to have a strong preference for their stay after a bariatric procedure. The preference is equally divided between outpatient and inpatient surgery and is not influenced by any patient characteristics.

Postoperative circadian patterns in wearable sensor measured heart rate: a prospective observational study.

PURPOSE: This study aimed to describe the 24-hour cycle of wearable sensor-obtained heart rate in patients with deterioration-free recovery and to compare it with patients experiencing postoperative deterioration. METHODS: A prospective observational trial was performed in patients following bariatric or major abdominal cancer surgery. A wireless accelerometer patch (Healthdot) continuously measured postoperative heart rate, both in the hospital and after discharge, for a period of 14 days. The circadian pattern, or diurnal rhythm, in the wearable sensor-obtained heart rate was described using peak, nadir and peak-nadir excursions. RESULTS: The study population consisted of 137 bariatric and 100 major abdominal cancer surgery patients. In the latter group, 39 experienced postoperative deterioration. Both surgery types showed disrupted diurnal rhythm on the first postoperative days. Thereafter, the bariatric group had significantly lower peak heart rates (days 4, 7-12, 14), lower nadir heart rates (days 3-14) and larger peak-nadir excursions (days 2, 4-14). In cancer surgery patients, significantly higher nadir (days 2-5) and peak heart rates (days 2-3) were observed prior to deterioration. CONCLUSIONS: The postoperative diurnal rhythm of heart rate is disturbed by different types of surgery. Both groups showed recovery of diurnal rhythm but in patients following cancer surgery, both peak and nadir heart rates were higher than in the bariatric surgery group. Especially nadir heart rate was identified as a potential prognostic marker for deterioration after cancer surgery.

The impact of hospital experience in bariatric surgery on short-term outcomes after minimally invasive esophagectomy: a nationwide analysis.

BACKGROUND: Minimally invasive esophagectomy (MIE) is a technically challenging procedure with a substantial learning curve. Composite volume of upper gastrointestinal (upper GI) procedures for cancer has been previously linked to postoperative outcomes. This study aimed to investigate an association between hospital experience in bariatric surgery and short-term outcomes in MIE. METHOD: Data on esophagectomy patients between 2016 and 2020 were collected from the Dutch Upper Gastrointestinal Cancer Audit, a mandatory nationwide registry. Hospitals were categorized as bariatric or non-bariatric. Multivariable logistic regression investigated short-term postoperative outcomes, adjusting for case mix. RESULTS: Of 3371 patients undergoing esophagectomy in sixteen hospitals, 2450 (72.7%) underwent MIE. Bariatric hospitals (N = 6) accounted for 1057 (43.1%) MIE. Annual volume of bariatric procedures was median 523 and esophagectomies 42. In non-bariatric hospitals, volume of esophagectomies was median 52 (P = 0.145). Overall postoperative complication rate was lower in bariatric hospitals (59.2% vs. 65.9%, P < 0.001). Bariatric hospitals were associated with a reduced risk of overall complications (aOR 0.76 [95% CI 0.62-0.92]), length of hospital (aOR 0.79 [95% CI 0.65-0.95]), and ICU stay (aOR 0.81 [95% CI 0.67-0.98]) after MIE. Surgical radicality (R0) did not differ. Lymph node yield (≥ 15) was lower in bariatric hospitals (90.0% vs. 94.7%, P < 0.001). Over the years, several short-term outcomes improved in bariatric hospitals compared to non-bariatric hospitals. CONCLUSION: In this nationwide analysis, there was an association between bariatric hospitals and improved short-term outcomes after MIE. Characteristics of bariatric hospitals that could explain this phenomenon and whether this translates to other upper GI procedures may be warranted to identify.

Comparing patient reported abdominal pain between patients treated with oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) and primary colorectal cancer surgery.

Oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy (PIPAC-OX) is an emerging palliative treatment for patients with unresectable colorectal peritoneal metastases. Previously, our study group reported that patients experienced abdominal pain for several weeks after PIPAC-OX. However, it is unknown how this compares to abdominal pain after regular colorectal cancer surgery. To provide some perspective, this study compared the presence of abdominal pain after PIPAC-OX to the presence of abdominal pain after primary tumor surgery. Patient reported abdominal pain scores (EORTC QLQ-CR-29), from two prospective, Dutch cohorts were used in this study. Scores ranged from 0 to 100, a higher score represents more abdominal pain. Abdominal pain at baseline and at four weeks after treatment were compared between the two groups. Twenty patients who underwent PIPAC-OX and 322 patients who underwent primary tumor surgery were included in the analysis. At baseline, there were no differences in abdominal pain between both groups (mean 20 vs. 18, respectively; p = 0.688). Four weeks after treatment, abdominal pain was significantly worse in the PIPAC group (39 vs 15, respectively; p < 0.001; Cohen's d = 0.99). The differential effect over time for abdominal pain differed significantly between both groups (mean difference: 19 vs - 3, respectively; p = 0.004; Cohen's d = 0.88). PIPAC-OX resulted in significantly worse postoperative abdominal pain than primary tumor surgery. These results can be used for patient counseling and stress the need for adequate analgesia during and after PIPAC-OX. Further research is required to prevent or reduce abdominal pain after PIPAC-OX.Trial registration CRC-PIPAC: Clinicaltrails.gov NCT03246321 (01-10-2017).

Additional preparation program for bariatric surgery: Two-year results of a large cohort study.

Background: Multidisciplinary screening of bariatric surgery candidates is recommended, and some centers provide an additional preparation program (APP) to optimize patients preoperatively. Objective: To compare patients with APP to standard care 2 years after primary bariatric surgery regarding postoperative weight loss and resolution of obesity-related comorbidities. Methods: A retrospective cohort study was conducted for patients undergoing primary Roux-en-Y gastric bypass and sleeve gastrectomy between September 2017 and March 2019. The first 12 months patients received an APP, after September 2018, the APP was no longer part of the weight loss trajectory. A multivariable linear regression model was built. Results: Of the 384 patients receiving an APP advice, 50 were lost to follow up. In total, 192 (57%) received the APP and 142 (43%) received standard care. Percentage total weight loss after 2 years was significantly different, 28.8% for the APP group versus 32% for the standard group (p = 0.001). Postoperative weight loss after 2 years was increased in patients who had a gastric bypass, a higher baseline body mass index, and female gender in multivariable analysis. An APP was predictive for decreased postoperative weight. Diabetes mellitus was in remission significantly more often in the preparation group (84.1% of the cases) compared with the standard group (61.9%, p = 0.028). Conclusion: A weight loss trajectory is at least as effective without additional preparation in terms of 2 years postoperative %TWL for primary gastric bypass and sleeve procedures. For comorbidities, diabetes mellitus was in remission more often in the APP group.