Septic shock and biliary sepsis: 90-day mortality and associated risk factors.

BACKGROUND: Biliary sepsis is common in patients with digestive cancer. Recommendations call for antibiotic de-escalation (ADE) as a strategy for antibiotic treatment of sepsis or septic shock. The aim of this study was to identify factors influencing 90-day mortality and to evaluate the impact of ADE. METHODS: This retrospective study was conducted between November 2008 and December 2019 in a referral cancer center. Adults with biliary sepsis or septic shock admitted to the ICU were included. Variables associated with 90-day mortality were identified using univariate and multivariate Cox proportional hazards models. RESULTS: 122 patients were included. The 90-day mortality was 30.3% (n = 37). After multivariate analysis, the factors independently associated 90-day mortality were metastatic stage (p = 0.004), biliary tract tumour compression (p = 0.001), multi drug resistant (MDR) bacteria carriage on intensive care unit (ICU)admission (p = 0.048), serum lactate on ICU admission (p < 0.001), the use of extra-renal replacement (p = 0.008), factor V < 50% (p = 0.009) and performance status (ECOG-PS) > 2 (p < 0.001). ADE of the pivotal antibiotic (p = 0.041) and recent cancer surgery (p < 0.001) appeared to be associated with survival. CONCLUSION: The 90-day mortality of biliary sepsis seems to be favourable. The 90-day mortality is associated with organ dysfunctions, but also with ECOG-PS, cancer stage, MDR bacteria colonisation. ADE seems to be safe.

Factors Associated with 1-Year Mortality in Elderly Patients (Age ≥ 80 Years) with Cancer Undergoing Major Abdominal Surgery: A Retrospective Cohort Study.

BACKGROUND: The number of elderly patients undergoing major abdominal surgery is increasing, but the factors affecting their postoperative outcomes remain unclear. This study aimed to identify the factors associated with 1-year mortality among elderly patients (age ≥ 80 years) with cancer undergoing major abdominal surgery. METHODS: This retrospective cohort study was conducted from March 2009 to December 2020. The study enrolled 378 patients 80 years old or older who underwent major abdominal surgery. The main outcome was 1-year mortality, and the factors associated with mortality were analyzed. RESULTS: Of the 378 patients, 92 died at 1 year (24.3%), whereas the 30-day mortality rate was 4% (n = 15). In the multivariate analysis, the factors independently associated with 1-year mortality were preoperative Eastern Cooperative Oncology Group (ECOG) performance status (PS) score higher than 1 (odds ratio [OR], 3.189; 95% confidence interval [CI], 1.595-6.377; p = 0.001), preoperative weight loss greater than 3 kg (OR, 2.145; 95% CI, 1.044-4.404; p = 0.038), use of an intraoperative vasopressor (OR, 3.090; 95% CI, 1.188-8.042; p = 0.021), and postoperative red blood cell units (OR, 1.212; 95% CI, 1.045-1.405; p = 0.011). Survival was associated with perioperative management according to an enhanced recovery after surgery (ERAS) protocol (OR, 0.370; 95% CI, 0.160-0.854; p = 0.006) and supramesocolic surgery (OR, 0.371; 95% CI, 0.158-0.871; p = 0.023). CONCLUSION: The study identified several factors associated with an encouraging 1-year mortality rate in this setting. These results highlight the need for identification of suitable targets to optimize pre-, intra-, and postoperative management in order to improve outcomes for this vulnerable population.

LATE POSTPANCREATICODUODENECTOMY HEMORRHAGE: INCIDENCE, RISK FACTORS, MANAGEMENT AND OUTCOME.

ABSTRACT: Background:Postpancreaticoduodenectomy (PD) hemorrhage (PPH) is a life-threatening complication after PD. The main objective of this study was to evaluate incidence and factors associated with late PPH as well as the management strategy and outcomes. Methods: Between May 2017 and March 2020, clinical data from 192 patients undergoing PD were collected prospectively in the CHIRPAN Database (NCT02871336) and retrospectively analyzed. In our institution, all patients scheduled for a PD are routinely admitted for monitoring and management in intensive/intermediate care unit (ICU/IMC). Results: The incidence of late PPH was 17% (32 of 192), whereas the 90-day mortality rate of late PPH was 19% (6 of 32). Late PPH was associated with 90-day mortality (P = 0.001). Using multivariate analysis, independent risk factors for late PPH were postoperative sepsis (P = 0.036), and on day 3, creatinine (P = 0.025), drain fluid amylase concentration (P = 0.023), lipase concentration (P < 0.001), and C-reactive protein (CRP) concentration (P < 0.001). We developed two predictive scores for PPH occurrence, the PANCRHEMO scores. Score 1 was associated with 68.8% sensitivity, 85.6% specificity, 48.8% predictive positive value, 93.2% negative predictive value, and an area under the receiver operating characteristic curves of 0.841. Score 2 was associated with 81.2% sensitivity, 76.9% specificity, 41.3% predictive positive value, 95.3% negative predictive value, and an area under the receiver operating characteristic curve of 0.859. Conclusions: Routine ICU/IMC monitoring might contribute to a better management of these complications. Some predicting factors such as postoperative sepsis and biological markers on day 3 should help physicians to determine patients requiring a prolonged ICU/IMC monitoring.

Location of ischemia and ischemic pain intensity affect spatiotemporal parameters and leg muscles activity during walking in patients with intermittent claudication.

The ways in which locations of ischemia and ischemic pain affect spatiotemporal gait parameters and leg electromyographic activity during walking have never been investigated in patients with peripheral arterial disease presenting intermittent claudication. Two groups were classified according to unilateral location of ischemia (distal, n = 10, or proximo-distal, n = 12). Patients described pain and three gait phases-initial pain-free, onset of pain and maximum pain-were analyzed. Patients with proximo-distal ischemia walked less (230 ± 111 m vs 384 ± 220 m), with increased step length, step time (+ 5.4% and + 5.8%) and reduced cadence (- 8.2%), than patients with distal ischemia. In both, the peaks of vertical ground reaction force were reduced in maximum pain (Peak1-distal: - 11.4%, Peak1-proximo-distal: - 10.3%; Peak2-distal: - 11.8%, Peak2-proximo-distal: - 9.0%). In the proximo-distal group, tibialis anterior activation peak and time were lower than in the distal group (- 4.5% and - 19.7%). During the maximum pain phase, this peak decreased only in the proximo-distal group (- 13.0%), and gastrocnemius medialis activation peak and time decreased in both groups (- 2.5% in distal and - 4.5% in proximo-distal). Thus, proximo-distal ischemia leads to more adverse consequences in gait than distal ischemia only. Increasing ischemic pain until maximum, but not onset of pain, induced gait adaptations.

Gait alterations in patient with intermittent claudication: Effect of unilateral vs bilateral ischemia.

BACKGROUND: We seek to evaluate whether ischemia extent (unilateral or bilateral) impacts spatiotemporal and neuromuscular gait parameters differently in patients with peripheral arterial disease and presenting intermittent claudication (PAD-IC). METHODS: Two groups of PAD-IC patients: unilateral (Unilat-IC; n = 15), bilateral (Bilat-IC; n = 15) and a group of control subjects with similar risk factors (n = 15) were evaluated during a constant load treadmill walking test. Spatiotemporal parameters and neuromuscular activation in tibialis anterior and gastrocnemius medialis were recorded. Patients were instructed to describe their pain during walking test, and three phases were analysed: pain-free, onset of pain and maximum pain in PAD-IC patients. FINDINGS: Single leg stance in the asymptomatic leg of Unilat-IC increases and becomes higher than the symptomatic leg and the Bilat-IC legs at maximum pain. Step time is higher and cadence is lower in PAC-IC than in controls. Tibialis anterior activation peak in Unilat-IC continuously decreases between phases and becomes lower than in Bilat-IC during maximum pain. Tibialis anterior activation time is higher in Bilat-IC and in the asymptomatic leg than in the symptomatic of Unilat-IC during all the phases. Gastrocnemius medialis activation peak in Bilat-IC decreases with pain. Gastrocnemius medialis activation time in the symptomatic leg of Unilat-IC presents a significant decrease between pain-free and maximum pain phases. INTERPRETATION: Ischemia impacts gait in PAD-IC patients differently according to its extent between legs compared to controls. Imbalance between legs in Unilat-IC induces compensatory mechanism and an asymmetrical pattern. Bilat-IC should not be simply considered as a 'double' Unilat-IC when evaluating gait.

Interactions among obesity and age-related effects on the gait pattern and muscle activity across the ankle joint.

OBJECTIVE: The purposes of this study were to investigate the combined effects of age and obesity on gait and to analyze the relationship between age and obesity on ankle muscle activities during walking. MATERIALS AND METHODS: 4 groups; the young non-obese control group (CG, n = 50, age = 31.8 ± 4.5 years; BMI = 21.4 ± 2.2 kg/m2), the young obese group (OB, n = 30, age = 35.4 ± 4.1 years; BMI = 38.6 ± 3.5 kg/m2), the non-obese older adults group (OA, n = 20, age = 76.1 ± 3.5 years; BMI = 24.4 ± 1.1 kg/m2) and the obese older adults group (OBOA, n = 20, age = 79.6 ± 5.7 years; BMI = 35.5 ± 2.7 kg/m2) walked on an instrumented gait analysis treadmill at their preferred walking speed. Spatiotemporal parameters, walking cycle phases, Vertical ground reaction force (GRFv) and center of pressure (CoP) velocity were sampled from the treadmill software. Electromyography (EMG) activity of the gastrocnemius medialis (GM), the soleus (SOL) and tibialis anterior (TA) were also collected during the walking test. A forward stepwise multiple regression analysis was performed to determine if body weight or age could predict ankle muscle activities during the different walking cycle phases. RESULTS: Compared to OB, OBOA walked with higher CoP velocity, shorter stride, spending more time in support phase (p < .05). These manifestations were associated with higher TA and SOL activities during the 1st double support (1st DS) and higher TA activity during the single support (SS) (p < .05). Compared to OA, OBOA walked with lower GRFv, shorter and wider stride and spend more time in SU (p < .05). Moreover, SOL, TA and GM activities of OBOA were higher compared to OAG during 1st DS, SS and 2nd Double support (2nd DS), respectively (p < .05). During the 1ST DS, the stepwise multiple regression revealed that age accounted for 87% of the variance of TA activity. The addition of age contributed a further 16% to explain the variance TA activity. During the SS, age accounted for 64% and 46% of the variance of SOL and TA activity respectively. The addition of the body weight added further 15% and 66% of the variation of SOL and TA activity respectively. During the 2nd DS, body weight accounted for 86% of the variance and the addition of the body weight added a further 17% to explain the high level of GM. CONCLUSION: Age in obese adults and obesity in older adults should be considered separately to evaluate neuromuscular responses during walking and, subsequently, optimize the modality of treatment and rehabilitation processes in obese individuals in order to reduce and/or prevent the risk of falls.

PhysIOpathology of NEuromuscular function rElated to fatigue in chronic Renal disease in the elderly (PIONEER): study protocol.

BACKGROUND: Chronic Kidney Disease (CKD) is associated with reduced muscular strength resulting in profound fatigue. The physiopathology of these changes, their prevalence and evolution are still debated. Moreover, we have little data on elderly CKD patients. The present study protocol aims to 1) quantify the prevalence of low muscle strength (dynapenia) in a cohort of elderly patients with advanced CKD and to 2) characterize their force production coupled with electromyographic features and the symptoms of fatigue compared to a matched control group. METHODS: This is a case-control, prospective, interventional study. INCLUSION CRITERIA: age ≥ 60 years; CKD Stage 3b-5; clinical stability (i.e. no hospitalization and ≤ 25% in creatinine increase in the previous 3 months). Controls with normal kidney function will be matched in terms of age, gender and diabetes mellitus (requisite: estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 available in the last 6 months). Exclusion criteria for cases and controls: neuromuscular disease, life expectancy < 3 months. The handgrip strength protocol is an intermittent test consisting in 6 series of 9 repetitions of 3-s sub-maximum contractions at 40% of the maximum voluntary contraction (MVC) and 2 s of resting time between contractions. Each series is separated by one fast sub-maximum contraction and one MVC. Strength is assessed with a high-frequency handgrip dynamometer paired with surface electromyography. Symptoms of fatigue are assessed using MFI-20 and FACIT-F questionnaires. In order to reach a statistical power of 96%, we plan to enroll 110 subjects in each group. DISCUSSION: The novelty of this study resides in the application of an already validated set of tests in a population in which this combination (dynamometer, electromyography and questionnaires) has not previously been explored. We expect a high prevalence of dynapenia and a higher fatigability in CKD patients. A positive correlation is expected between reported fatigue and fatigability. Better appreciation of the prevalence and the relationship between fatigability and a sensation of fatigue can help us target interventions in CKD patients to improve quality of life and survival. TRIAL REGISTRATION: The study was approved by Ethical Committee EST III n°20.03.01 and was recorded as a Clinical Trial (NCT04330807) on April 2, 2020.

EVAN-G score in patients undergoing minimally invasive gynecology oncologic surgery in an Enhanced Recovery After Surgery (ERAS) program.

INTRODUCTION: Enhanced Recovery After Surgery (ERAS) has been proven to decrease the length of hospital stay without increasing re-admission rates or complications. There are limited data on the satisfaction of patients undergoing minimally invasive surgery for gynecologic malignancy within ERAS programs. The aim of this study was to evaluate patient satisfaction after minimally invasive surgery for gynecologic malignancy within the ERAS program using the 'Evaluation du Vécu de l'Anésthésie Génerale (EVAN-G)' questionnaire. METHODS: This observational retrospective study was conducted at the Paoli-Calmettes Institute between June 2016 and December 2018. All the included patients underwent minimally invasive surgery for a gynecologic malignancy. EVAN-G, a validated questionnaire, was used to measure peri-operative patient satisfaction. This questionnaire consists of 26 items assessing six elements: attention, privacy, information, pain, discomfort, and waiting time. Each element is assessed via a 5-step numerical scale and then transformed to a 0-100 scale according to the degree of satisfaction. The EVAN-G questionnaire was given to patients before surgery and collected during the post-operative consultation (2-3 weeks after surgery). RESULTS: A total of 175 patients underwent minimally invasive surgery for gynecologic malignancy within the ERAS program. Of these, 92 patients were included in the study and 83 patients were excluded. The overall patient compliance rate with our ERAS program was 90%. The analysis of the EVAN-G score of all participants showed an overall high level of satisfaction with a mean score of 81.9 (range 41.6-100). Patients with peri-operative complications or having prolonged hospitalization also showed high levels of satisfaction with a mean score of 80.5 (41.6-100) and 83.2(55-100), respectively. CONCLUSION: In this study we showed a high patient satisfaction with the ERAS program. When comparing length of stay and complications, neither extended length of stay nor development of complications after minimally invasive surgery impacted patient satisfaction.

Intraoperative Hemorrhagic Shock in Cancer Surgical Patients: Short and Long-Term Mortality and Associated Factors.

BACKGROUND: Management of hemorrhagic shock is well codified by international guidelines. These guidelines are predominantly based on trauma patients. We aimed to evaluate factors associated with 30-day mortality and long-term survival after intraoperative hemorrhagic shock during major oncological surgery. METHODS: This retrospective study was conducted in a cancer referral center from January 2013 to February 2018. All adult cancer patients admitted in the operative room for scheduled or emergency oncological surgery associated with an intraoperative hemorrhagic shock were included. RESULTS: Eighty-four patients were included in this study. The 30-day mortality rate was 26% (n = 22), the mean follow-up from the time of ICU admission was 20 months (95% CI, 15-25 months), 39 (46%) patients died during this period. Using logistic regression for multivariate analysis, factors independently associated with 30-day mortality were SAPS II score (odds ratio (OR) =1.056, 95% confident interval (CI) =1.010-1.1041), delta SOFA (SOFA score at day 3 - SOFA score at day 1) (OR= 1.780, 95% CI 1.184-2.677) and ISTH-DIC score (OR = 2.705, 95% CI 1.108-6.606). Using Cox multivariate analysis, factors associated with long-term mortality were delta SOFA (hazard ratio (HR) =1.558, 95% CI 1.298-1.870), ISTH-DIC score (HR = 1.381, 95% CI 1.049-1.817), hepatic dysfunction (HR = 7.653, 95% CI 2.031-28.842), and Charlson comorbidity index (HR = 1.330, 95% CI 1.041-1.699). CONCLUSION: The worsening of organ dysfunctions during the first 3 days of ICU admission as well as intraoperative coagulation disturbances (increased ISTH-DIC score) are independently associated with short and long-term mortality. Comorbidities (Charlson comorbidity index) and postoperative hepatic dysfunction were independently associated with long-term mortality. Early perioperative bundle strategies should be evaluated in order to improve patient's survival in this specific situation.

Impact of Power Output on Muscle Activation and 3D Kinematics During an Incremental Test to Exhaustion in Professional Cyclists.

This study aimed to quantify the influence of an increase in power output (PO) on joint kinematics and electromyographic (EMG) activity during an incremental test to exhaustion for a population of professional cyclists. The hip flexion/extension and internal/external rotation as well as knee abduction/adduction ranges of motion were significantly decreased at 100% of the maximal aerobic power (MAP). EMG analysis revealed a significant increase in the root mean square (RMS) for all muscles from 70% of the MAP. Gastrocnemius muscles [lateralis gastrocnemius (GasL) and medialis gastrocnemius (GasM)] were the less affected by the increase of PO. Cross-correlation method showed a significant increase in the lag angle values for VM in the last stage compared to the first stage, meaning that the onset of the activation started earlier during the pedaling cycle. Statistical Parametric Mapping (SPM) demonstrated that from 70% MAP, biceps femoris (BF), tibialis anterior (TA), gluteus maximus (GM), and rectus femoris (RF) yielded larger ranges of the crank cycle on which the level of recruitment was significantly increased. This study revealed specific muscular and kinematic coordination for professional cyclists in response to PO increase.

Prediction of early discharge after gynaecological oncology surgery within ERAS.

OBJECTIVES: Enhanced recovery after surgery programs (ERAS) have been proven to decrease the length of hospital stay without increasing readmission rates or complications. However, the patient and operative characteristics that improve the chance of a successful early hospital discharge are not well established. The aim of this study was to design a nomogram which could be used before surgery, using the characteristics of patients, to establish who could benefit from early discharge (POD ≤ 2 days). METHODS: This observational study has been prospectively conducted. All the included patients were referred for surgical treatment of gynecologic cancer. We defined two sub-groups of patients on surgical procedure characteristics: isolated procedures (hysterectomy or lymphadenectomy) and combined procedures (at least the association of two procedures). RESULTS: 230 patients were enrolled during the study protocol. 83.9% of patients were treated with a minimally invasive surgery (MIS). 159 patients (69.1%) were discharged on or before POD 2. On multivariate analysis, the surgical approach (open surgery vs. laparoscopy, OR 0.02 (95% CI [0-0.07]), p < 0.001) and the type of surgery (combined procedure versus isolated procedure, OR 0.41 (95% CI [0.18-0.91]), p = 0.028) were found to be significant predictors of increased hospital stay. A nomogram has been built for the purpose of predicting eligible patients for early post-operative discharge based on the multivariate analysis results (AUC = 0.86, 95% CI [0.81-0.92]). CONCLUSION: The use of MIS for isolated procedures in oncologic indications constitutes an independent factor of early discharge in a setting of ERAS. These promising preliminary results still require to be validated on a prospective cohort.

Enhanced recovery after surgery program in older patients undergoing gynaecologic oncological surgery is feasible and safe.

BACKGROUND: Enhanced Recovery After Surgery Programs (ERP) include multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS). By allowing patients to return rapidly to their everyday surroundings, older patients are those who could take the greatest benefit from ERP. This is the first study to date to assess feasibility and safety of ERP on older patients undergoing gynaecologic oncological surgery. METHODS: Data were prospectively collected between December 2015 and September 2017 at the Institut Paoli-Calmettes, a French comprehensive cancer centre. All the patients included in the study were referred for hysterectomy and/or pelvic or para-aortic lymphadenectomy for gynaecological cancer. The primary objective was to achieve similar LOS in patients ≥70 years old compared to younger patients without increasing the proportion of complications and readmission rates. A binary (LOS < or ≥ 2 days) logistic regression was built, including age, Charlson score, BMI, ASA score, oncological indication, surgical procedures and surgical approaches. G8 score was estimated for all the ≥70 years old patients. RESULTS: Of a total of 329 patients, 75 were ≥70 years old and 254 were <70. Except a disparity in oncological indications with a higher proportion of endometrial cancer in the ≥70 years old group (56% vs. 27%; p < 0.01), there were no differences in patient's characteristics and surgical procedures. Age ≥ 70 years was associated with a longer LOS (means, 3.88 vs. 3.11 days; p = 0.024) only in univariate analysis. Considering the logistic regression, age was no longer associated with LOS. Total hysterectomy with pelvic lymphadenectomy and ASA score ≥ 3 were independently associated with longer LOS while mini-invasive techniques were associated with a shorter LOS. Morbidities and readmissions occurred respectively in 23% and 8% of the total population without any difference between the two groups. In the ≥70 years old population, G8 score was not predictive of LOS, morbidities or readmissions. CONCLUSION: Although it is already widely accepted that ERP improves early recovery, our study shows that ERP for patients over 70 years of age undergoing gynaecologic oncological surgery is as safe and feasible as on younger patients.

Combined effects of aging and obesity on postural control, muscle activity and maximal voluntary force of muscles mobilizing ankle joint.

OBJECTIVE: The aim of the study was to investigate the influence of age and/or obesity on postural control, ankle muscle activities during balance testing and force production capacities. MATERIALS AND METHODS: 4 groups; control group (CG; n = 25; age = 31.8 ±â€¯7.5 years; BMI = 21.4 ±â€¯2.5 kg/m2), obese group (OG; n = 25; age = 34.4 ±â€¯9.5 years; BMI = 39.6 ±â€¯5.4 kg/m2), elderly group (EG; n = 15; age = 77.1 ±â€¯8.4 years; BMI = 24.4 ±â€¯1.3 kg/m2) and obese elderly group (ObEG; n = 12; age = 78.6 ±â€¯6.6 years; BMI = 34.5 ±â€¯3.1 kg/m2) performed maximal voluntary contraction (MVC) before testing to calculate the maximal relative force of ankle plantar flexor (PF) and dorsal flexor (DF) muscles. Center of pressure (CoP) parameters and the electromyography (EMG) activity of PF and DF muscles were collected during MVC, quiet standing and limit of stability (LoS) testing along antero-posterior and medio-lateral axes. RESULTS: Maximal relative force was higher in EG and ObEG than CG and OG, respectively (p < 0.001). CoP parameters, distance traveled along the antero-posterior axis and EMG activity of PF were higher in OG, EG and ObEG compared to CG (p < 0.001) and in EG compared to ObEG (p < 0.05).The EMG activity of PF was positively correlated with CoP parameters in OG and ObEG (r > 0.6; p < 0.05). Maximal relative force of PF (r > -0.6; p < 0.05) was negatively correlated with CoP parameters in ObEG and EG. CONCLUSION: Obesity-related postural control alteration is associated with increased activity of PF. This neuromuscular adaptation may reflect deteriorations of the proprioceptive system and is likely additional to age-related muscular impairments. This may be a mechanism by which obesity increases postural control alterations in elderly.

Spatiotemporal analysis of 3D kinematic asymmetry in professional cycling during an incremental test to exhaustion.

This study investigated the influence of an incremental exercise on bilateral asymmetry through the spatio-temporal evolution of 3D joint angular displacement, using the Normalized Symmetry Index ([Formula: see text]) and cross-correlation methods. Twelve professional cyclists performed an incremental test to exhaustion, during which motion capture was used. Results revealed a decrease in range of motion between the first and last stages for twelve of the eighteen joint rotations, with the highest impact observed for right hip flexion/extension (61.8 ± 4.7° to 58.8 ± 4.1°, p < 0.05, ES = 0.68). For both stages, significant bilateral differences greater than 10° were observed for hip and knee flexion/extension (p < 0.05, ES>0.90) and ankle and hip internal/external rotation (p < 0.05, ES>0.25). Cross-correlation displayed the lowest pattern similarities for hip abduction/adduction and the highest similarities for knee flexion/extension, ankle plantarflexion/dorsiflexion and hip internal/external rotation. The cross-correlation method showed that the right leg was mostly ahead of time with respect to the left leg, a trend that was accentuated with power output increase. Instantaneous [Formula: see text] fluctuated up to 18% throughout the pedalling cycle, with different behaviour between the power and recovery phases. This study demonstrated the workload effects on side-to-side joint angular pattern similarity.

Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial.

Importance: Hypnosis is now widespread in medical practice and is emerging as an alternative technique for pain management and anxiety. However, its effects on postoperative outcomes remain unclear. Objective: To evaluate the efficacy of a preoperative hypnosis session for reducing postoperative breast pain in patients who underwent minor breast cancer surgery. Design, Setting, and Participants: The HYPNOSEIN prospective randomized clinical trial was conducted from October 7, 2014, to April 5, 2016. In this multicenter study in France, 150 women scheduled for minor breast cancer surgery were randomized between control and hypnosis arms, and 148 (71 control and 77 hypnosis) were included in the intent-to-treat analysis. Intervention: On the day of surgery, eligible patients were randomly assigned (1:1) to the control arm or the hypnosis arm. Patients (but not the care teams) were blinded to the arm to which they were assigned. A 15-minute hypnosis session before general anesthesia in the operating room was performed in the hypnosis arm. Main Outcomes and Measures: The primary end point was breast pain reduction (by 2 on a visual analog scale), assessed immediately before discharge from the postanesthesia care unit (PACU). Secondary end points were nausea/vomiting, fatigue, comfort/well-being, anxiety, and PACU length of stay, assessed at different times until postoperative day 30. Results: The median patient age was 57 years (range, 33-79 years) in the control arm and 53 years (range, 20-84 years) in the hypnosis arm. Baseline characteristics were similar in the 2 arms. The median duration of the hypnosis session was 6 minutes (range, 2-15 minutes). The use of intraoperative opioids and hypnotics was lower in the hypnosis arm. The mean (SD) breast pain score (range, 0-10) was 1.75 (1.59) in the control arm vs 2.63 (1.62) in the hypnosis arm (P = .004). At PACU discharge and with longer follow-up, no statistically significant difference in breast pain was reported. Fatigue was significantly lower in the hypnosis arm on the evening of surgery (mean [SD] score, 3.81 [2.15] in the control arm vs 2.99 [2.56] in the hypnosis arm; P = .03). The median PACU length of stay was 60 minutes (range, 20-290 minutes) in the control arm vs 46 minutes (range, 5-100 minutes) in the hypnosis arm (P = .002). Exploratory analyses according to patient perception of whether she received hypnosis showed significantly lower fatigue scores in the perceived hypnosis subgroup on the evening of surgery (mean [SD], 4.13 [2.26] for no perceived hypnosis vs 2.97 [2.42] for perceived hypnosis; P = .01). Anxiety was also significantly lower on the evening of surgery in the perceived hypnosis subgroup (mean [SD], 0.75 [1.64] for perceived hypnosis vs 1.67 [2.29] for no perceived hypnosis; P = .03). Conclusions and Relevance: The results of this study do not support a benefit of hypnosis on postoperative breast pain in women undergoing minor breast cancer surgery. However, other outcomes seem to be improved, which needs to be confirmed by further studies. Trial Registration: EudraCT Identifier: 2014-A00681-46 and ClinicalTrials.gov Identifier: NCT03253159.