ERAS with or without supplemental artificial nutrition in open pancreatoduodenectomy for cancer. A multicenter, randomized, open labeled trial (RASTA study protocol)

PurposeThe role of supplemental artificial nutrition in patients perioperatively treated according to enhanced recovery programs (ERAS) on surgery-related morbidity is not known. Therefore, there is a need of a clinical trials specifically designed to explore whether given a full nutritional requirement by parenteral feeding after surgery coupled with oral food “at will” compared to oral food “at will” alone, within an established ERAS program, could achieve a reduction of the morbidity burden.Materials and analysisRASTA will be a multicenter, randomized, parallel-arm, open labeled, superiority trial. The trial will be conducted in five Italian Institutions with proven experience in pancreatic surgery and already applying an established ERAS program. Adult patients (age ≥ 18 and < 90 years of age) candidate to elective open pancreatoduodenectomy (PD) for any periampullary or pancreatic cancer will be randomized to receive a full ERAS protocol that establishes oral food “at will” plus parenteral nutrition (PN) from postoperative day 1 to day 5 (treatment arm), or to ERAS protocol without PN (control arm). The primary endpoint of the trial is the complication burden within 90 days after the day of surgery. The complication burden will be assessed by the Comprehensive Complication Index, that incorporates all complications and their severity as defined by the Clavien-Dindo classification, and summarizes postoperative morbidity with a numerical scale ranging from 0 to 100. The H0 hypothesis tested is that he administration of a parenteral nutrition added to the ERAS protocol will not affect the CCI as compared to standard of care (ERAS). The H1 hypothesis is that the administration of a parenteral nutrition added to the ERAS protocol will positively affect the CCI as compared to standard of care (ERAS). The trial has been registered at ClinicalTrials.gov (number: NCT04438447; date: 18/05/2020).ConclusionThis upcoming trial will permit to establish if early postoperative artificial nutritional support after PD may improve postoperative outcomes compared to oral nutrition alone within an established ERAS program

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA):an international randomised non-inferiority trial

Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson &amp; Johnson Medical Limited, Dutch Gastroenterology Society.</p

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA):an international randomised non-inferiority trial

Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson &amp; Johnson Medical Limited, Dutch Gastroenterology Society.</p

Evolving trends in the management of acute appendicitis during COVID-19 waves. The ACIE appy II study

Background: In 2020, ACIE Appy study showed that COVID-19 pandemic heavily affected the management of patients with acute appendicitis (AA) worldwide, with an increased rate of non-operative management (NOM) strategies and a trend toward open surgery due to concern of virus transmission by laparoscopy and controversial recommendations on this issue. The aim of this study was to survey again the same group of surgeons to assess if any difference in management attitudes of AA had occurred in the later stages of the outbreak. Methods: From August 15 to September 30, 2021, an online questionnaire was sent to all 709 participants of the ACIE Appy study. The questionnaire included questions on personal protective equipment (PPE), local policies and screening for SARS-CoV-2 infection, NOM, surgical approach and disease presentations in 2021. The results were compared with the results from the previous study. Results: A total of 476 answers were collected (response rate 67.1%). Screening policies were significatively improved with most patients screened regardless of symptoms (89.5% vs. 37.4%) with PCR and antigenic test as the preferred test (74.1% vs. 26.3%). More patients tested positive before surgery and commercial systems were the preferred ones to filter smoke plumes during laparoscopy. Laparoscopic appendicectomy was the first option in the treatment of AA, with a declined use of NOM. Conclusion: Management of AA has improved in the last waves of pandemic. Increased evidence regarding SARS-COV-2 infection along with a timely healthcare systems response has been translated into tailored attitudes and a better care for patients with AA worldwide

The impact of adherence to enhanced recovery pathway elements on outcomes following bowel surgery

Introduction: Enhanced recovery pathways (ERPs) are evidence-based, multimodal, standardized care plans that integrate multiple steps and interventions in the perioperative period aiming to improve patient recovery after surgery. International guidelines recommend the incorporation of a large number of interventions into ERPs. However, the impact of overall adherence to the pathway and the relative contribution of each intervention are unclear. The objective of the research contained within this thesis is two-fold: (1) to estimate the extent to which adherence to care process is associated with outcomes, and identify key ERP elements associated with successful recovery following bowel resection; (2) to assess the validity and usability of a novel mobile device app for patient education and self-reporting of adherence within an established ERP. Methods: A review of prospectively collected data entered in a registry specifically designed for ERPs was performed. Patients undergoing elective bowel resection between 2012 and 2014 at the Montreal General Hospital treated within an ERP comprising 23 care elements were included in the study. Primary outcome was successful recovery defined as: absence of complications, discharge by postoperative day 4 and no readmission. Secondary outcomes were: length of hospital stay (LOS), 30-day morbidity and severity (Comprehensive complication index, CCI, 0-100). Subsequently, we performed a prospective pilot study implementing a novel mobile device app specifically designed to provide patients with daily recovery milestones and to record adherence to different ERP processes and patient reported outcomes (PROs). Validity was measured by the agreement index (Cohen's kappa coefficient for categorical, and interclass correlation coefficient (ICC) for continuous variables) between patient reported data through the app and data recorded by a clinical auditor. Acceptability and usability of the app were measured by the System Usability Scale (SUS). Results: In our retrospective study, we analyzed data from 347 patients, with a median length of hospital stay of 4 days (IQR 3-7), and median adherence to 18 (IQR 16-20) elements. There was a positive association between adherence and successful recovery with no hospital readmission, length of stay, 30-day postoperative morbidity and the complication severity. Laparoscopy, early mobilization out of bed, and early termination of IV fluid infusion were significantly associated with improved outcomes. In our app validation study, we included 45 patients undergoing bowel surgery. Overall, patients completed 89% of the available perioperative questionnaires through the app. Substantial (kappa > 0.6) or almost-perfect agreement (kappa > 0.8) and strong correlation (ICC > 0.7) between data collected through the app and by the clinical auditor was found for 14 out of 15 ERP processes and 4 out of 6 PROs. Patient reported usability and satisfaction was high, and only few patients needed technical support to use the app. Forty (89%) patients found that the app was helpful to achieve their daily goals, and 34 (76%) thought it increased their motivation to recover after surgery. Conclusion: In an established ERP where overall adherence was high, we found that increased adherence to ERP interventions was associated with successful early recovery and a reduction in postoperative morbidity and complication severity. Given the significant impact of adherence to postoperative elements, we successfully piloted a novel mobile device app which proved to be a valid tool to record patient adherence and patient reported outcomes, and had high usability and patient satisfaction. Our findings suggest that future studies should investigate the use of mobile device apps as strategies to increase adherence to ERP interventions and improve outcomes.Introduction: Les programmes multidisciplinaires de récupération accélérée (PMRA) sont des plans de soins standardisés, multimodaux et fondés sur des preuves. Les directives internationales recommandent l'incorporation de nombreuses interventions dans les PMRA. Cependant, l'impact de l'adhésion à ces programmes ainsi que la contribution relative de chaque intervention ne sont pas clairs. L'objectif principal de cette thèse est double: (1)estimer dans quelle mesure l'adhésion au processus de soins est associé aux résultats, et identifier les éléments clés de PMRA qui sont associés au rétablissement après une résection intestinale; (2)évaluer la validité et la convivialité d'une application mobile novatrice utilisée pour l'éducation des patients et pour l'auto-déclaration d'adhésion à un PMRA établi. Méthodes: Un registre spécifiquement conçu pour les PMRA qui contient des données recueillies prospectivement a été révisé. Les patients qui ont subi une chirurgie intestinale élective entre 2012 et 2014 à l'Hôpital général de Montréal et dans le cadre d'un PMRA qui comporte 23 éléments de soins ont été inclus dans l'étude. Le résultat principal a été le rétablissement avec succès défini comme: l'absence de complications, sortie d'hôpital au plus tard le quatrième jour après la chirurgie, et pas de réhospitalisation. Ensuite, nous avons effectué une étude pilote prospective qui met en œuvre une application mobile novatrice conçue pour les patients postopératoire. L'application indique les jalons quotidiens, permet l'enregistrement d'adhésion aux différents processus PMRA et recueillit les résultats déclarés par les patients ("Patient-reported outcomes", PRO). La validité a été mesurée par l'indice d'accord (le coefficient Kappa de Cohen pour les variables catégoriques, et le coefficient de corrélation interclasse (ICC) pour les variables continues) entre les données recueillies par l'application et les données enregistrées par l'auditeur clinique. Résultats: Dans notre étude rétrospective, nous avons analysé les données de 347 patients, avec une durée médiane de l'hospitalisation de 4 jours(écart interquartile 3-7), et en moyenne, adhésion à 18 éléments du PMRA(écart interquartile 16-20). Il y a eu une association positive entre l'adhésion et le rétablissement sans réhospitalisation, la durée du séjour, et la gravité des complications ainsi que la morbidité postopératoire à 30 jours. La laparoscopie, la mobilité précoce, et la cessation précoce des solutions intraveineuses a été associées à de meilleurs résultats de manière significative. Pour notre étude sur la validité de l'application mobile, nous avons inclus 45 patients qui subissent une chirurgie intestinale. Un accord substantiel (kappa > 0.6) ou un accord presque parfait(kappa > 0.8) et une forte corrélation(ICC > 0.7) entre les données recueillies par l'application et par l'auditeur clinique ont été retrouvés pour 14 processus du PMRA sur 15 et pour 4 PRO sur 6. Les patients ont déclaré un niveau de convivialité et de satisfaction élevé. Quarante(89%) patients croyaient que l'application a aidé à atteindre leurs objectifs quotidiens, et 34(76%) patients croyaient qu'elle a augmenté leur motivation de rétablissement après la chirurgie. Conclusion: L'étude a conclu que le plus une adhésion aux interventions PMRA a été élevée, le plus elle a été associée à un rétablissement accéléré et à une réduction de la gravité des complications et la morbidité postopératoire. Étant donné l'impact significatif d'adhésion sur les éléments postopératoires, nous avons réussi à piloter une application mobile novatrice et valide, capable d'enregistrer l'adhésion au PMRA et les PRO. Elle est également associée à un haut niveau de convivialité et de satisfaction. Selon nos constations, les recherches futures devraient viser à évaluer l'utilisation des application mobiles comme des stratégies pour l'augmentation d'adhésion aux interventions PMRA et pour de meilleurs résultats postopératoires

Pancreatic metastases: An increasing clinical entity

Pancreatic metastases, although uncommon, have been observed with increasing frequency recently, especially by high-volume pancreatic surgery centers. They are often asymptomatic and detected incidentally or during follow-up investigations even several years after the removal of the primary tumor. Renal cell cancer represents the most common primary tumor by far, followed by colorectal cancer, melanoma, sarcoma and lung cancer. Pancreatic metastasectomy is indicated for an isolated and resectable metastasis in a patient fit to tolerate pancreatectomy. Both standard and atypical pancreatic resection can be performed: a resection strategy providing adequate resection margins and maximal tissue preservation of the pancreas should be pursued. The effectiveness of resection for pancreatic metastases is mainly dependent on the tumor biology of the primary cancer; renal cell cancer is associated with the best outcome with a 5-year survival rate greater than 70%

Long-term outcomes after laparoscopic colectomy

AIM: To evaluate long-term outcomes in a large series of patients who randomly received laparoscopic or open colorectal resection

Laparoscopic Versus Open Left Pancreatectomy: Short Term Outcome and Cost-Benefit Analysis

Context An increasing number of surgeons are today performing laparoscopic left pancreatectomy (LLP), since available nonrandomized studies demonstrated its feasibility, safety and oncologic adequacy. However, most existing data come from small single-institution reports or from heterogeneously composed multicenter comparisons. Moreover, there is very limited information about economic implications of minimally invasive pancreatic surgery. Objective This study reports our experience in laparoscopic left pancreatectomy compared with open technique (OLP), assessing perioperative outcomes and financial impact of this procedure in a high volume surgical setting. Methods Between February 2009 and June 2011 we performed 112 left pancreatectomies, 53 of which (47%) were LLP. Excluding the initial learning curve, the remaining 43 patients were matched with a control group selected from our perspective electronic database. Match criteria were gender, age, ASA score, BMI, lesion site, malignant or benign disease. Results Mean operative time was similar (LLP 216±61 min; OLP 214±7 min; P=0.885), blood loss was reduced in LLP (388±371 mL vs. 571±599 mL, P=0.092), especially in cancer patients (514±350 mL vs. 946±787 mL, P=0.072); intraoperative transfusion and unplanned splenectomy rates were similar. Larger lesions were associated with increased unplanned splenectomy rate. Conversion rate (CR) was 18%; higher BMI (&gt;30 kg/m2) and pancreatic body site were associated with increased CR. There were no differences in positive margin rates, number of nodes examined and number of N1 patients. There was no mortality in both groups. Overall morbidity was equable (63% in LLP, 60% in OLP; P=0.958), as well as major complication rate (7% in LLP, 3% in OLP; P=0.604). Clinically significant pancreatic fistula rate was 14% in LLP and 9% in OLP (P=0.728). No grade C fistulas were observed. An equal proportion of patients in each group was discharged before removing surgical drain. Delayed gastric empting, wound and urinary tract infection were more frequent in OLP. Mean LOS was 8.37 days in LLP vs. 8.81 days in OLP (P=0.481); LOS in non complicated patients was 6.96 days in LLP vs. 7.50 days in OLP (P=0.220). Mean number of diagnostic test, transfusion rate, antibiotic administration and readmission rate were similar. Each patient of LLP group saved €168.47 because of shorter LOS and slightly fewer complication cost, generating however an extra cost of €767,01 due to more expensive surgical instruments. Conclusion This study confirms safety and oncologic adequacy of this technique, identifying probable risk factors for conversion and demonstrating economic sustainability of LLP. Final balance still have to be realized considering indirect costs as shorter home convalescence, quality of life and better cosmetic result