Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY).

BACKGROUND: Post-induction anaesthesia often promotes intraoperative hypotension (IOH) that can worsen postoperative outcomes. This study aims to assess the benefit of norepinephrine versus ephedrine at the induction of anaesthesia to prevent postoperative complications following major abdominal surgery by preventing IOH. METHODS AND ANALYSIS: The EPON STUDY is a prospective single-centre randomised controlled trial with the planned inclusion of 500 patients scheduled for major abdominal surgery at the Amiens University Hospital. The inclusion criteria are patients aged over 50 years weighing more than 50 kg with an American Society of Anesthesiologists physical status score of ≥2 undergoing major abdominal surgery under general anaesthesia. Patients are allocated either to the intervention group (n=250) or the standard group (n=250). In the intervention group, the prevention of post-induction IOH is performed with norepinephrine (dilution to 0.016 mg/mL) using an electric syringe pump at a rate of 0.48 mg/h (30 mL/h) from the start of anaesthesia and then titrated to achieve the haemodynamic target. In the control group, the prevention of post-induction IOH is performed with manual titration of ephedrine, with a maximal dose of 30 mg, followed by perfusion with norepinephrine. In both groups, the haemodynamic target to maintain is a mean arterial pressure (MAP) of 65 mm Hg or 70 mm Hg for patients with a medical history of hypertension. An intention-to-treat analysis will be performed. The primary outcome is the Clavien-Dindo score assessed up to 30 days postoperatively. The secondary endpoints are the length of hospital stay and length of stay in an intensive care unit/postoperative care unit; postoperative renal function; postoperative cardiovascular, respiratory, neurological, haematological and infectious complications at 1 month; and volume of intraoperative vascular filling and mortality at 1 month. ETHICS AND DISSEMINATION: Ethical approval was obtained from the committee of protection of the persons of Ile de France in May 2021 (number 21 05 41). The authors will be involved in disseminating the research findings (through attending conferences and co-authoring papers). The results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT05276596.

Short-term Outcomes of Day-Case Stoma Closure: A Prospective, Observational Study.

BACKGROUND: Elective stoma closure is a common, standardized procedure in digestive surgery. OBJECTIVE: This study aimed to evaluate the feasibility of day-case surgery for elective stoma closure. DESIGN: This is a prospective, single-center, nonrandomized study of consecutive patients undergoing day-case elective stoma closure. SETTING: This study was performed at a French tertiary hospital between January 2016 and June 2018. PATIENTS: Elective stoma closure was performed by local incision with an ASA score of I, II, or stabilized III. OUTCOME MEASURES: The primary end point was the day-case surgery success rate in the overall population (all patients having undergone elective stoma closure) and in the per protocol population (patients not fulfilling any of the preoperative or perioperative exclusion criteria). The secondary end points (in the per protocol population) were the overall morbidity rate (according to the Clavien-Dindo classification), the major morbidity rate (Clavien score ≥3), and day-case surgery quality criteria (unplanned consultation, unplanned hospitalization, and unplanned reoperation). RESULTS: Between January 2016 and June 2018, 236 patients (the overall population; mean ± SD age: 54 ± 17; 120 men (51%)) underwent elective stoma closure. Fifty of these patients (21%) met all the inclusion criteria and constituted the per protocol population. The day-case surgery success rate was 17% (40 of 236 patients) in the overall population and 80% (40 of 50 patients) in the per protocol population. In the per protocol population, the overall morbidity rate was 30% and the major morbidity rate was 6%. Of the 40 patients with successful day-case surgery, the unplanned consultation rate and the unplanned hospitalization rate were both 32.5%. There were no unplanned reoperations. LIMITATIONS: This was a single-center study. CONCLUSION: In selected patients, day-case surgery for elective stoma closure is feasible and has acceptable complication and readmission rates. Day-case elective stoma closure can therefore be legitimately offered to selected patients. See Video Abstract at http://links.lww.com/DCR/B583. RESULTADOS A CORTO PLAZO DEL CIERRE DE ESTOMA AMBULATORIO UN ESTUDIO OBSERVACIONAL Y PROSPECTIVO: ANTECEDENTES:El cierre electivo de un estoma es un procedimiento común y estandarizado en cirugía digestiva.OBJETIVO:Evaluar la viabilidad de la cirugía ambulatoria para el cierre electivo de estomas.DISEÑO:Un estudio prospectivo, unicéntrico, no aleatorizado de pacientes consecutivos sometidos a cierre de estoma electivo ambulatorio.ESCENARIO:Un hospital terciario francés entre enero de 2016 y junio de 2018.PACIENTES:Cierre electivo de estoma realizado por incisión local con una puntuación de la American Society of Anesthesiologists de I, II o III estabilizado.PRINCIPALES MEDIDAS DE RESULTADO:El resultado principal fue la tasa de éxito de la cirugía ambulatoria en la población general (todos los pacientes habiendo sido sometidos a cierre de estoma electivo) y en la población por protocolo (pacientes que no cumplían con ninguno de los criterios de exclusión preoperatorios o perioperatorios). Los resultados secundarios (en la población por protocolo) fueron la tasa de morbilidad general (según la clasificación de Clavien-Dindo), la tasa de morbilidad mayor (puntuación de Clavien ≥ 3) y los criterios de calidad de la cirugía ambulatoria (consulta no planificada, hospitalización no planificada y reoperación no planificada).RESULTADOS:Entre enero de 2016 y junio de 2018, 236 pacientes (la población general; edad media ± desviación estándar: 54 ± 17; 120 hombres (51%)) se sometieron al cierre electivo del estoma. Cincuenta de estos pacientes (21%) cumplieron todos los criterios de inclusión y constituyeron la población por protocolo. La tasa de éxito de la cirugía ambulatoria fue del 17% (40 de 236 pacientes) en la población general y del 80% (40 de 50 pacientes) en la población por protocolo. En la población por protocolo, la tasa de morbilidad general fue del 30% y la tasa de morbilidad mayor fue del 6%. De los 40 pacientes con cirugía ambulatoria exitosa, la tasa de consultas no planificadas y la tasa de hospitalización no planificada fueron ambas del 32.5%. No hubo reoperaciones no planificadas.LIMITACIONES:Este fue un estudio de un solo centro.CONCLUSIÓN:En pacientes seleccionados, la cirugía ambulatoria para el cierre electivo de estoma es factible y tiene tasas aceptables de complicaciones y reingreso. Por lo tanto, se puede ofrecer legítimamente el cierre electivo ambulatorio de estoma a pacientes seleccionados. Consulte Video Resumen en http://links.lww.com/DCR/B583.

Laparoscopic sleeve gastrectomy as day-case surgery: a case-matched study.

BACKGROUND: Few series have demonstrated the feasibility of laparoscopic sleeve gastrectomy (SG) as day-case surgery (DCS). OBJECTIVE: Compare the outcomes and healthcare costs of SG performed as DCS or as an inpatient procedure. SETTING: University Hospital, France, public practice. METHODS: This was a prospective, nonrandomized study of 250 consecutive patients undergoing day-case SG from May 2011 to June 2017. Each patient in the DCS group (n = 250) was manually paired by sex, age, body mass index, preoperative co-morbidities, and year of surgery with 1 patient undergoing SG as an inpatient procedure (SG control group, n = 250). Patients in the SG control group were excluded from DCS on the basis of DCS criteria. The primary endpoint of this study was the clinical and economic impact of performing SG as DCS compared with inpatient management. The secondary endpoints were related to DCS, DCS satisfaction rate, comparison of outcomes and costs between DCS and inpatient procedures, and the changing modalities of SG as DCS in our institution (by comparing the first 100 patients to the last 150 patients). RESULTS: A total of 1573 patients underwent SG during the period, 250 patients underwent SG as DCS (15.9%) and 554 patients were excluded on the basis of DCS criteria. No postoperative deaths, 19 overnight admissions (7.6%), 16 unscheduled consultations (6.4%), and 12 unscheduled hospitalizations (4.8%) were observed in the DCS group. No significant differences were observed in postoperative complications. Readmission was higher in the DCS group (5.6% versus 4%; P < .001), while the length of rehospitalization was shorter in the DCS group (5.8 versus 10.8 d; P < .001). Overall cost and cost per patient were significantly lower in the DCS group (P < .001). CONCLUSION: Day-case SG on selected patients was not associated with increased morbidity and mortality rates and was cost-effective due to the low cost of management of postoperative complications.

Minor laparoscopic liver resection as day-case surgery (without overnight hospitalisation): a pilot study.

BACKGROUND: Day-case surgery (DCS) has become increasingly popular over recent years, as has laparoscopic liver resection (LLR) for the treatment of benign or malignant liver tumours. The purpose of this prospective study was to demonstrate the feasibility of minor LLR as DCS. METHODS: Prospective, intention-to-treat, non-randomised study of patients undergoing minor LLR between July 2015 and December 2017. Exclusion criteria were resection by laparotomy, major LLR, difficult locations for minor LLR, history of major abdominal surgery, hepatobiliary procedures without liver parenchyma resection, cirrhosis with Child > A and/or portal hypertension, significant medical history and exclusion criteria for DCS. The primary endpoint was the unplanned overnight admission rate. Secondary endpoints were the reason for exclusion, complication data, criteria for DCS evaluation, satisfaction and compliance with the protocol. RESULTS: One hundred sixty-seven patients underwent liver resection during the study period. LLR was performed in 92 patients (55%), as DCS in 23 patients (25%). Reasons for minor LLR were liver metastasis (n = 9), hepatic adenoma (n = 5), hepatocellular carcinoma (n = 4), ciliated hepatic foregut cyst (n = 2) and other benign tumours (n = 3). All day-case minor LLR, except two patients, consisted of single wedge resection, while one patient underwent left lateral sectionectomy. There were four unplanned overnight admissions (17.4%), one unscheduled consultation (4.3%), two hospital readmissions (8.6%) and no major complications/mortality. Compliance with the protocol was 69.5%. Satisfaction rate was 91%. CONCLUSION: In selected patients, day-case minor LLR is feasible with acceptable complication and readmission rates. Day-case minor LLR can therefore be legitimately proposed in selected patients.

Satisfaction rate of patients undergoing sleeve gastrectomy as day-case surgery compared to conventional hospitalization: a prospective non-randomized study.

PURPOSE: Day-case surgery (DCS) has boomed over recent years. However, day-case bariatric surgery remains controversial due to a lack of evaluation. The objective of this study was to compare the experiences and satisfaction with general anesthesia of patients undergoing sleeve gastrectomy (SG) as DCS compared to conventional hospitalization. METHODS: Between January 2015 and June 2016, all patients undergoing primary SG as day-case surgery or with conventional hospitalization were prospectively included in this non-randomized, non-inferiority study comparing the level of satisfaction of patients undergoing SG with conventional hospitalization (CH group, gold standard) versus SG as DCS (DCS group). The primary efficacy endpoint was comparison of the overall satisfaction rate using the EVAN-G questionnaire. The secondary endpoints were evaluation of the 6 dimensions of the EVAN-G questionnaire, discharge from hospital, adhesion with SG management and overall satisfaction with SG. RESULTS: One-hundred and twenty-four patients met the inclusion criteria (62 in both groups). The DCS group was younger with fewer comorbidities (p ≤ 0.01) and had a lower BMI (p ≤ 0.01). Overall, the mean EVAN-G questionnaire score was 66.4 (63.9-68.9) for the DCS group and 68.9 (65.9-71.8) for the CH group (non-inferiority of DCS group). In the DCS group, 19% of patients would have preferred to spend the night in hospital, while 82% of patients in the CH group would have preferred DCS and a total of 75% of patients reported a high level of satisfaction. CONCLUSION: Overall satisfaction of patients undergoing SG as day-case surgery was not inferior to that of patients managed by conventional hospitalization.

Benefits of Laparoscopic Approach for Resection of Liver Tumors in Cirrhotic Patients.

INTRODUCTION: Liver resection in cirrhotic patients is associated with increased morbidity and mortality. The objective of this study was to compare short-term results of laparoscopic resection (LR) and open surgery (OS) for minor liver resection in patients with hepatocellular carcinoma (HCC) hepatocellularcarcinoma on nontumor cirrhotic liver (HCC/F4) and patients with colorectal cancer liver metastases (CRLMs) colorectal liver metastases on healthy liver (CRLM/F0). MATERIALS AND METHODS: Between January 2005 and December 2014, all patients undergoing liver resection (n = 754) were included in this study. Liver resections for cholangiocarcinoma or benign tumor, major liver resection (≥3 segments), HCC on healthy liver, CRLM on cirrhotic liver, and liver resection with technically difficult accessibility (segments I, VII, and VIII) were excluded. The primary endpoint of the study was a validated composite endpoint (CEP), which included specific liver surgery complications (Clavien ≥III), allowing comparison of the postoperative course after LR versus OR for HCC/F4 patients and CRLM/F0 patients using propensity score (PS) analysis. Secondary endpoints were major postoperative morbidity according to the Clavien-Dindo classification (≥III) and intensive care unit (ICU) length of hospital stay (LOS) and overall LOS. The test group was defined as HCC/F4 patients operated by LR, and the control group was defined as HCC/F4 patients and CRLM/F0 patients operated by OS and CRLM/F0 patient operated by LR. RESULTS: Sixty patients (38.7%) underwent LR and 95 patients (61.3%) underwent OS. Surgery was performed for CRLM in 93 patients (60%) and for HCC in 62 patients (40%). No difference was demonstrated between HCC/F4 patients and CRLM/F0 patients in the LR group in terms of the CEP (7% versus 18.1%; P = .23), while a significant difference for the CEP was observed between HCC/F4 patients and CRLM/F0 patients after OS (50% versus 21%; P = .021). A higher rate of CEP was observed for HCC/F4 patients operated by OS compared to HCC/F4 patients operated by LR (50% versus 7.8%; P = .009). No significant difference in Clavien-Dindo score ≥III was observed between HCC/F4 patients and CRLM/F0 patients operated by LR (10% versus 4.5%; P = .98). A higher postoperative ascites rate was observed for HCC/F4 patients operated by OS compared to CRLM/F0 patients operated by OS (25% versus 2.8%; P = .006). This difference was no longer observed when HCC/F4 patients were compared to CRLM/F0 operated by LR (7.8% versus 2.8%; P = .09). The postoperative mortality rate was 1.8% and was not correlated with nontumor liver or surgical approach. A shorter LOS was observed for HCC/F4 patients operated by LR compared to HCC/F4 patients operated by OS (7.53 versus 17.13; P = .011). CONCLUSION: The laparoscopic approach for malignant liver tumor is associated with a lower specific complication rate. LR for HCC/F4 could eliminate excess morbidity and decrease LOS in patients with cirrhotic liver.

Outpatient laparoscopic sleeve gastrectomy: first 100 cases.

STUDY OBJECTIVE: The development of outpatient surgery was one of the major goals of public health policy in 2010. The purpose of this observational prospective study was to evaluate the feasibility of laparoscopic sleeve gastrectomy (SG) in an ambulatory setting. DESIGN: Study design was a prospective prospective observational, nonrandomized study, registered (ClinicalTrials.gov identifier: NCT01513005), with institutional review board approval and written informed consent. SETTING: Amiens University Medical Center. PATIENTS: Patients undergoing SG who were preselected by inclusion ambulatory criteria. INTERVENTIONS: All patients operated on for obesity by laparoscopic SG, from May 2011 through July 2013. MEASUREMENTS: We collected outcomes data on 100 patients including incidence of postoperative nausea and vomiting, maximum and average pain scores, and the overall satisfaction rate. MAIN RESULTS: Of the 100 obese patients, 93% were women. The mean age was 36 years (22-55 years). The mean preoperative body mass index was 42.4 kg/m(2). The mean operating time was 60 minutes (range, 30-95 minutes). The overall satisfaction rate was 93% (n = 93). When leaving the postoperative care unit, 94% of patients felt no or mild pain. Eighty-two percent had no postoperative postoperative nausea and vomiting, and 7 patients needed treatment using ondasetron. CONCLUSIONS: Laparoscopic SG in an ambulatory setting is feasible with a dedicated anesthesiological approach and an expert surgical team. Appropriate patient selection is important for ensuring safety and quality of care within the outpatient program.

Reversal of neuromuscular blockade by sugammadex in laparoscopic bariatric surgery: In support of dose reduction.

INTRODUCTION: Sugammadex is the first molecule able to antagonize steroidal muscle relaxants with few adverse effects. Doses are adjusted to body weight and the level of neuromuscular blockade. Sleeve gastrectomy is becoming a very popular form of bariatric surgery. It requires deep muscle relaxation followed by complete and rapid reversal to decrease postoperative and especially post-anaesthetic morbidity. Sugammadex is therefore particularly indicated in this setting. The objective of this study was to evaluate the deep neuromuscular blockade reversal time after administration of various doses of sugammadex (based on real weight or at lower doses). Secondary endpoints were the interval between the sugammadex injection and extubation and transfer from the operating room to the recovery room. We then investigated any complications observed in the recovery room. MATERIALS AND METHODS: This pilot, prospective, observational, clinical practice evaluation study was conducted in the Amiens University Hospital. Neuromuscular blockade was induced by rocuronium. At the end of the operation, deep neuromuscular blockade was reversed by sugammadex at the dose of 4mg/kg. RESULTS: Sixty-four patients were included: 31 patients received sugammadex at a dosage based on their real weight (RW) and 33 patients received a lower dose (based on ideal weight [IW]). For identical rocuronium doses calculated based on IBW, sugammadex doses were significantly lower in the IW group: 349 (± 65) mg versus 508 (± 75) mg (P<0.0001). Despite this dose reduction, neuromuscular blockade reversal took 115 (± 69) s in the IW group versus 87 (± 40) s in the RW group, but with no significant difference between the two groups (P=0.08). The intervals between injection of sugammadex and extubation (P=0.07) and transfer from the operating room to the recovery room (P=0.68) were also non-significantly longer in the IW group. The mean dose of sugammadex used by anaesthetists in the IW group was 4mg/kg of ideal weight increased by 35% to 50% (n=20; 351±34mg). No sugammadex adverse effects and no residual neuromuscular blockades were observed. Postoperative nausea and vomiting (PONV) was observed in 19.4% of patients in the real weight group versus 27.3% in the ideal weight group (P=NS). CONCLUSION: Reversal of deep neuromuscular blockades by sugammadex in obese subjects can be performed at doses of 4mg/kg of ideal weight plus 35-50% with no clinical consequences and no accentuation of adverse effects.

Is sleeve gastrectomy still contraindicated for patients aged≥60 years? A case-matched study with 24 months of follow-up.

BACKGROUND: Current guidelines consider that bariatric surgery is relatively contraindicated in elderly adults (aged≥60 years). The objective of this study was to evaluate obesity-related morbidity after sleeve gastrectomy (SG) according to whether patients were aged≥60 years or<60 years. METHODS: Forty-two patients aged≥60 years (the elderly group) were matched 1:2 with 84 patients aged<60 (the control group). The primary objective was to compare weight change and the remission rate of co-morbidities in the 2 groups after 24 months of follow-up. The secondary endpoints were short-term and midterm postoperative outcomes (operating time, the frequency of conversion to laparotomy, the length of hospital stay, postoperative complications, mortality, and the SG failure rate). RESULTS: No significant differences were observed between the elderly and control groups in terms of the mean operating time (83 minutes in both groups; P = .90), length of stay (3.2 versus 3.4 days, respectively; P = .51), morbidity rate (4.7% versus 9.5%, P = .35), or mortality rate (0% in both groups). The mean excess weight loss was significantly lower in the elderly group than in the control group at 12 months (56.2% versus 71.4%, respectively; P<.01) and 24 months (51.8% versus 73.5%, P<.01). Similar statistically significant differences were observed between the elderly group and control group for remission of metabolic syndrome (95% versus 90%, respectively; P = .55), type 2 diabetes mellitus (87% versus 71%, respectively; P = .13), hypertension (81% versus 77%, respectively; P = .71), and dyslipidemia (94% versus 74%, respectively; P = .09) at 24 months after SG. CONCLUSION: Results support the safety and efficacy of SG for morbid obesity in patients aged≥60 years. In contrast to weight loss, the long-term morbidity rate and remission of obesity-related co-morbidities were similar in the participants aged≥60 years and those aged<60 years.

Laparoscopic sleeve gastrectomy as day-case surgery (without overnight hospitalization).

BACKGROUND: Day-case surgery (DCS) has boomed over recent years, as has laparoscopic sleeve gastrectomy (SG) for the treatment of morbid obesity. The objective of this study was to evaluate the safety and feasibility of day-case SG. METHODS: This was a prospective, nonrandomized study of 100 patients undergoing day-case SG from May 2011 to July 2013. All patients met the criteria for DCS and for the treatment of morbid obesity. Standard surgical, anesthetic, and analgesic protocols were used. The primary study endpoint was the unplanned overnight admission rate. Secondary endpoints were standard DCS criteria, frequency and type of complications, and satisfaction rate of performing day-case SG. The short-term postoperative course of patients undergoing day-case and conventional SG also were compared. RESULTS: A total of 416 patients were screened and 100 (24%) were included. There were 8 unplanned overnight admissions. Seven unexpected consultations, 7 hospital readmissions, and 5 major complications were recorded, including 3 cases of unexpected surgery for gastric leak. At follow-up, 96% of the patients were satisfied with day-case SG. The short-term postoperative course was similar among patients undergoing DCS and conventional management. CONCLUSION: In selected patients, day-case SG is feasible with acceptable complication and readmission rates. The postoperative course was similar to that observed for standard SG.

Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding.

BACKGROUND: Sleeve gastrectomy (SG) is an alternative to gastric bypass and laparoscopic adjustable gastric banding (GB). METHODS: From January 2004 to January 2006, 111 patients with a follow-up longer than 24 months were prospectively followed. Three treatment groups were defined. Sleeve gastrectomy as first procedure (SGFP; n = 50), sleeve gastrectomy after failure of GB (SG after GB; n = 9) and GB (n = 52). We compared morbidity, mortality, length of stay, number of procedures under general anaesthesia, excess weight loss (EWL) and quality of life. RESULTS: Mean initial body mass index (BMI) was 50.4 (SG), 50.8 (SG after GB) and 43.8 (GB; p = 0.000001). Mean operating time was 97.1 min (SGFP), 122.2 min (SG after GB) and 69.8 min (GB; p < 0.0001). The reoperation rate under general anaesthesia was 2% (SGFP), 11% (SG after GB) and 30.76% (GB; p = 0.00001).The fistula rate was 2% (SGFP), 0% (SG after GB) and 0% (GB). BMI at 24 months was 33.8 (SGFP), 35.3 (SG after GB) and 33.2 (GB; NS). EWL at 24 months was 67.4 (SGFP), 60.3 (SG after GB) and 58.6 (GB; NS). In the SGFP group and in the SG after GB group, the mean quality-of-life score was 1.1. In the GB group, the mean score was 0.95 (NS). CONCLUSIONS: Initial BMI was significantly higher in the SG group but was no longer significantly different from the BMI of the GB group at 12 and 24 months. Excess BMI loss was higher after SG than after GB. This reduction of BMI was considered to be a success for GB. Thus, results of SG should be considered as a success. Quality of life was not significantly different between the three groups. These results validated SG as first procedure or after failure of GB.

[Bariatric surgery in the treatment of severe obesity]. / Place de la chirurgie dans la prise en charge de l'obésité morbide.

Over the past ten years, the treatment of severe obesity has radically changed through the benefits of bariatric surgery not only on weight loss significant and lasting, but also on reducing mortality, correction of metabolic disorders, reduction of cardiovascular risk and improving the quality of life. Its indication should be multidisciplinary. Laparoscopy has become the rule, reducing the postoperative morbimortality. Four types of intervention are regularly performed in France. We report their principle, their results and major complications.