[KINE PREOP pilot study: Prehabilitation in fast-track thoracic surgery protocol]. / KINE PREOP : réhabilitation préopératoire libérale et chirurgie thoracique pulmonaire.

INTRODUCTION: Prehabilitation preceding oncological thoracic surgery according to a fast-track enhanced recovery after surgery (ERAS) protocol is in full expansion. Many recent studies have demonstrated the benefits of preoperative pulmonary rehabilitation as a means of reducing postoperative pulmonary complications. Unfortunately, it is rarely carried out by independent physiotherapists, and questions arise: is it feasible in private practice? Can it yield results similar to those achieved in institutional settings? DESIGN: The study was non-interventional. The patients included had to be able to practice physical activities according to a standard ERAS approach. The endpoints were: postoperative pulmonary complications, physical condition (VO2max), and impact on the quality of life (SF-36 questionnaire). A statistical study was conducted to analyze the results with parametric and non-parametric tests. RESULTS: Between June 2018 and January 2019, nine patients were included. From two to fifteen pulmonary rehabilitation sessions were carried out by six volunteering independent physiotherapists. Only two minor postoperative complications ensued. VO2max post rehabilitation increased on average by 2.4mL.kg -1.min-1. The SF-36 physical score increased significantly (+17.9%). The physical functioning (PF) (+28.9), physical restrictions (PR) (+11.1) and vitality (VT) (+16.7) sub-scores likewise improved. CONCLUSION: Based on a literature review and on comparisons, our results seem promising. While further investigations are needed, it would seem that prehabilitation by independent physiotherapists leads to results similar to those achieved in inpatient prehabilitation.

Comparison of first versus second line sacrocolpopexies in terms of morbidity and mid-term efficacy.

To compare pelvic organ prolapse (POP) recurrence and morbidity between first and second line sacrocolpopexies. We conducted a retrospective chart review of all laparoscopic or robotic sacrocolpopexies for POP-Q stage ≥ 2, with or without a history of previous prolapse repair, performed with a similar technique between January 2012 and June 2019 in 3 European Gynecologic Surgery Departments. Patients were separated into two groups: first line sacrocolpopexy (FLS) and second line sacrocolpopexy (SLS). Each patient from the SLS group was age-matched with a patient from the FLS group. The primary outcome measure was reoperation procedures for recurrent POP defined as a symptomatic POP-Q stage ≥ 2 POP in at least one vaginal compartment. Secondary outcomes included operative time, intraoperative organ trauma, intraoperative blood loss, postoperative POP recurrence (operated on or not), global reoperation and mesh-related complications. During this period, 332 patients were included. After age-matching, 170 patients were analyzed: 85 patients in the FLS and SLS groups, respectively. After a mean follow-up of 3 years, there was no statistically significant difference between the two groups in terms of recurrent POP (9.4% versus 10.6%, p = 0.7), recurrent POP reoperation (3.5% versus 5.9% p = 0.7), mesh-related reoperation (0% versus 2.4%, p = 0.5), global reoperation (3.5 versus 8.2%, p = 0.3), operative time (198 ± 67 min versus 193 ± 60 min, p = 0.5), intraoperative complications such as organ injury (4.7% versus 7.1%, p = 0.7) and blood loss > 500 mL (2.4% versus 0%, p = 0.5). Patients who underwent a first or a second line sacrocolpopexy seemed to have similar rates of prolapse recurrence and complications.

Evaluating the morbidity and long-term efficacy of laparoscopic sacrocolpopexy with and without robotic assistance for pelvic organ prolapse.

OBJECTIVE: The aim of our study was to compare the morbidity and long-term efficacy after laparoscopic sacrocolpopexy with and without robotic assistance. METHODS: We conducted a retrospective chart review of all laparoscopic or robotic sacrocolpopexies for POP-Q stage 2-4 vaginal prolapse performed between September 2015 and October 2018 in 2 Gynecologic Surgery Departments of France. Patients were separated into two groups: a laparoscopic sacrocolpopexy group (LS) and a robotic-assisted sacrocolpopexy group (RAS). The primary outcome measure was reoperation procedures for recurrent pelvic organ prolapse (POP). RESULTS: Two hundred and fourteen patients were included, 160 patients (75%) in the LS group and 54 patients (25%) in the RAS group. After a mean follow-up of 32.8 months, reoperation rate for recurrent POP and the recurrent POP rate were greater in the RAS group (9.2% versus 1.2%, p = 0.01 and 25.9% versus 7.5%, p = 0.0003, respectively). No significant difference was found in terms of immediate intraoperative (3.1% versus 1.8%, p = 1) and postoperative complications (1.9% versus 1.8%, p = 1). On comparing the 2 groups by bivariate analysis, RAS significantly increased the odds of reoperation for POP recurrence (OR = 7.8 CI 95% [1.5-41.6], p = 0.02) and the odds of global reoperation (OR = 3.8 CI 95% [1.4-10.4], p = 0.0095). Similarly, multivariate logistic analysis showed that RAS increased the risks of global reoperation (OR = 3.8 CI 95% [1.3-10.6], p = 0.01) after controlling high-grade prolapse. CONCLUSION: Robotic sacrocolpopexy does not appear to give long-term clinical benefits. Recurrent POP and reoperation procedures seem to be more frequent in case of robotic-assisted surgery.

The RAPID-II Neuropsychological Test battery for subjects aged 20 to 49 years: Norms and cognitive profile.

INTRODUCTION: Cognitive evaluation of young subjects is now widely carried out for non-traumatic diseases such as multiple sclerosis, HIV, or sleep disorders. This evaluation requires normative data based on healthy adult samples. However, most clinicians use a set of tests that were normed in an isolated manner from different samples using different cutoff criteria. Thus, the score of an individual may be considered either normal or impaired according to the norms used. It is well established that healthy adults obtained low-test scores when a battery of tests is administered. Thus, the knowledge of low base rates is required so as to minimize false diagnosis of cognitive impairment. The aim of this study was twofold (1) to provide normative data for RAPID-II battery in healthy adults, and (2) estimate the proportion of healthy adults having low scores across this battery. METHODS: Norms for the 44 test scores of the RAPID-II test battery were developed using the overall sample of 335 individuals based on three categories of age (20 to 29, 30 to 39, and 40 to 49 years) and two educational levels: Baccalaureate or higher educational degree (high educational level), lower than baccalaureate (low educational level). The 5th, 25th, 50th, and 75th percentiles were calculated from the six age and education subsamples and used to define norms. The frequency of low scores on the RAPID-II battery was calculated by simultaneously examining the performance of 33 primary scores. A low score was defined as less than or equal to the 5th percentile drawn from the six age and education normative subsamples. In addition, the percentages of low scores were also determined when all possible combinations of two-test scores across the RAPID-II were considered in the overall normative sample. RESULTS: Our data showed that 59.4% subjects of the normative sample obtained at least one or more low score. With more than 9 test scores, this percentage was equal to 0% in the normative sample. Among all combinations of two-test scores, 96% had a false positive rate<2%. CONCLUSION: Low scores are very common in young healthy subjects and are more obvious when simultaneously analyzing test scores across a battery of tests and are thus not necessarily indicative of cognitive impairment. The combinations of two-test scores can be a useful tool to improve the interpretation of low scores.

Implementation of intensity-modulated radiotherapy for head and neck cancers in routine practice.

PURPOSE: To report on patterns of relapse following implementation of intensity-modulated radiotherapy and subsequent changes in practice in a tertiary care centre. PATIENTS AND METHODS: Between 2008 and 2011, 188 consecutive patients (mean age 59 years old) received intensity-modulated radiotherapies with curative intent for squamous cell carcinomas of the oral cavity (17.5%), oropharynx (43%), hypopharynx (21%), larynx (14%), sinonasal cavities (6%), nasopharynx (1.5%) at the university hospital of Besançon. There were stage I and II 9%, III 24.5%, IV 66.5%. One hundred and thirty-eight underwent exclusive intensity-modulated radiotherapy, 50 underwent postoperative intensity-modulated radiotherapy, 174 had concurrent chemotherapy, 57 had induction chemotherapy. Dynamic intensity-modulated radiotherapy with static fields was performed for all patients using sequential irradiation in 174 patients and simultaneous integrated boost irradiation in 14 patients. RESULTS: With a median follow-up was 27.5 months, there was 79% of locoregional failures occurred in the 95% isodose. Two-year overall survival, disease-free, local failure-free and locoregional failure-free survival rates were73%, 60%, 79% and 72%, respectively. Prognostic factors for disease-free survival were stage (IV vs. I-III) with a relative risk of 1.7 [1.1-2.8] (P=0.02) and T stage with 1.6 [1.04-2.5] (P=0.03). CONCLUSION: The current series showed similar patterns of failure as in other tertiary care centres. We did not identify intensity-modulated radiotherapy specific relapse risks.

Long-term assessment of effectiveness and quality of life of OnabotulinumtoxinA injections in provoked vestibulodynia.

BACKGROUND: Provoked vestibulodynia is a relatively common condition that affects sexual activity. Multidisciplinary care is indicated and OnabotulinumtoxinA injections are safe and effective treatment in this indication. AIMS: To assess the long-term efficacy of OnabotulinumtoxinA in provoked vestibulodynia. MATERIALS AND METHODS: Twenty-one patients treated with OnabotulinumtoxinA injections (50U in each bulbospongiosus muscle) 24 months prior to the study were included. Data on pain [assessed using a visual analogue scale (VAS)], quality of life [measured by the Dermatology Life Quality Index (DLQI)] and quality of sex life [assessed using the Female Sexual Function Index (FSFI)] were collected before treatment, and 3 and 24 months after injection. RESULTS: Nineteen patients participated in the study and 37% had no pain after 24 months. Significant improvements were noted in the VAS, DLQI and FSFI scores between baseline and 24 months post treatment (P < 0.0001). After 24 months, 18 patients (95%) were able to have sexual intercourse. This study was open and non-controlled. DISCUSSION AND CONCLUSION: 100U OnabotulinumtoxinA injections constitute an effective treatment in provoked vestibulodynia with results maintained after 2 years. They significantly improve pain, and have a positive impact on patient quality of life and sex life. Beneficial effects continue in the long-term, allowing patients to resume sexual activity.

[Assessment of 10 years of memory consultations in the Franche-Comté: Description and analysis of the RAPID regional database]. / Bilan de 10ans de consultations mémoire en Franche-Comté: description et analyse de la base de données RAPID.

The aim of this study was to evaluate the impact, on a regional scale (Franche-Comté), of 3 National Alzheimer care plans, particularly concerning the development of the offer of care management by clinicians as well as the panel of diagnoses concerned. Data on sociodemographic, neuropsychological and diagnostic characteristics were retrieved from the RAPID regional database between 1st January 2003 and 31st December 2012. These analyses focused exclusively on patients who had an initial consultation (n=12,017) during the same period. The existence of a previously established health network capable of carrying out governmental health plans has produced an effective interface between regional administrative structures responsible for the implementation of these plans and health professionals responsible for carrying out them out. This network study, the use of a battery of tests and a common software database have enabled the development of patient care management throughout the Franche-Comté region. It also showed the diversification of diagnoses mentioned over the past years as well as changes in clinical practices on how to address the issue of cognitive impairment.

[Evaluation of a predictive score for malnutrition in patients treated by irradiation for head and neck cancer: a retrospective study in 127 patients]. / Évaluation d'un score prédictif de dénutrition chez les patients pris en charge par irradiation pour un cancer des voies aérodigestives supérieures : étude rétrospective chez 127 patients.

PURPOSE: The purpose of this study was to establish a pre-therapeutic score that could predict which patients would be at high risk of enteral tube feeding during (chemo)-radiotherapy for head and neck cancer. PATIENTS AND METHODS: A monocentric study was conducted retrospectively on patients receiving a radiotherapy or concurrent chemoradiotherapy for a head and neck cancer. A logistic model was performed in order to assess clinical or therapeutic risk factors for required artificial nutrition during treatment. Significant parameters, issued from multivariate analysis, were summed and weighted in a score aiming at estimating a malnutrition risk during radiotherapy. RESULTS: Among the 127 evaluated patients, 59 patients required artificial nutrition during radiotherapy. In multivariate analysis, predictive factors for malnutrition were weight loss superior to 5% in the 3 months before radiotherapy, advanced tumor stage (III-IV vs. I-II), and pain requiring strong analgesics (step II-III vs. I). Concurrent chemotherapy was identified as a significant risk factor also, but it was strongly correlated with the tumor stage. The score, estimated from these previous factors, allowed a prediction of a risk of enteral feeding with a sensitivity of 90% and a specificity of 85%. CONCLUSION: A predictive score of enteral nutrition before radiotherapy of head and neck cancer should be a useful clinical tool to target the patients who would need a prophylactic gastrostomy. Our study evidenced some risk factors of malnutrition requiring artificial feeding. However, we need a prospective study to confirm the validity of this score.

Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial.

PURPOSE: Few studies have evaluated the quality of life (QoL) of patients with rectal cancer. This report describes the quality of life of French patients who entered the 22921 EORTC trial that investigated the role and place of chemotherapy (CT) added to preoperative radiotherapy (preop-RT). PATIENTS AND METHODS: Patients without recurrences were evaluated with EORTC QLQ-C30 and QLQ-CR38 questionnaires, after a median time of 4.6 years from randomisation. RESULTS: All the scores of QLQ-C30 functions were high, from 78 up to 88, with those of global health quality of life scale (GHQL) status being 73. The mean scores of symptoms were low except for diarrhoea. For QLQ-CR38, the mean scores for "body image" and "future perspective" were high at 79.6 and 69.7 respectively. The scores for "sexual functioning" and "enjoyment" were low. Men had more sexual problems than females (62.5 vs 25 mean scores respectively). Chemotherapy was associated with more diarrhoea complaints, lower "role", lower "social functioning" and lower global health quality of life scale. CONCLUSION: The overall quality of life of patients with rectal cancer is quite good 4.6 years after the beginning preoperative treatments. However, adding chemotherapy to preoperative radiotherapy has a negative effect on diarrhoea complaints and some quality of life dimensions.

Efficacy and safety of an insulin infusion protocol during and after cardiac surgery.

AIM: Perioperative tight blood glucose (BG) control using insulin therapy after major surgery is a difficult, time-consuming task that also raises some concerns over the risk of severe hypoglycaemia. The aim of the present prospective study was to evaluate the efficacy and safety of an insulin therapy protocol in use at our institution. METHODS: A total of 230 consecutive patients (mean+/-SD age: 67+/-11 years; diabetic patients: n=62) undergoing cardiac surgery (coronary artery bypass grafting: n=137; 20% off-pump) or intrathoracic aortic (n=10) surgery were included. BG control was managed according to an insulin therapy protocol, described by Goldberg et al. (2004) [11], in use for 6 months in our intensive care unit. Insulin infusion rate and frequency of BG monitoring were both adjusted according to: (1) the current BG value; (2) the previous BG value; and (3) the current insulin infusion rate. Efficacy was assessed by the percentage of time spent at the target BG level (100-139 mg/dL) intraoperatively and during the first 2 postoperative days (POD). RESULTS: All patients received postoperative insulin therapy. Patients spent 57.3% and 69.7% of time within the BG target range on POD 1 and 2, respectively. The percentage of time was significantly higher in nondiabetics than in diabetics. Mean BG measurements per patient intraoperatively, on POD 1 and on POD 2 were 4+/-1, 10+/-2 and 7+/-2, respectively. No patient experienced any severe hypoglycaemic events (BG<50mg/dL). CONCLUSION: This study showed that a BG target of 100-139 mg/dL can be safely achieved with an insulin therapy protocol that can be routinely used in everyday clinical practice.

Blood warm reperfusion: a necessary adjunct to heart-valve surgery in low-risk patients?

AIM: The aim of this prospective, randomized study was to determine whether blood warm reperfusion improves myocardial protection provided by cold crystalloid cardioplegia in patients undergoing first-time elective heart-valve surgery, using cardiac troponin I release as the criterion for evaluating the adequacy of myocardial protection. METHODS: Seventy patients with a left ventricular ejection fraction greater than 40% were randomly assigned to 1 of 2 myocardial protection strategies: 1) cold crystalloid cardioplegia with no reperfusion or 2) cold crystalloid cardioplegia followed by 2-minute blood warm reperfusion before aortic unclamping. Cardiac troponin I concentrations were measured in serial venous blood samples drawn immediately prior to cardiopulmonary bypass and after aortic unclamping at 6, 9, 12, and 24 h. RESULTS: Randomization produced 2 equivalent groups. The total amount of cardiac troponin I released (7.17+/- 14.8 mg in the crystalloid cardioplegia with no reperfusion group and 5.82+/-4.66 mg in the crystalloid cardioplegia followed by blood warm reperfusion group) was not different (P > 0.2). Cardiac troponin I concentration did not differ for any sample in either of the 2 groups. The total amount of cardiac troponin I released was higher in patients who required inotropic support (9.14 +/-16.2 mg) than those who did not (4.73+/-4.52 mg; P = 0.009). CONCLUSIONS: Our study shows that adding blood warm reperfusion to cold crystalloid cardioplegia provides no additional myocardial protection in low-risk patients undergoing heart-valve surgery.

French version of FACT-G: validation and comparison with other cancer-specific instruments.

The aim of this study was to assess the validity of the French version of the Functional Assessment of Cancer Therapy - General (FACT-G), and to compare its psychometric properties with those of two other cancer-specific quality of life questionnaires, European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (EORTC QLQ-C30) and Functional Living Index - Cancer (FLIC). Two hundred and twenty three patients with breast or colorectal cancer completed the FACT-G questionnaire in French followed by (in random order) the QLQ-C30 and FLIC. An additional 87 patients with head and neck (H&N) cancer completed the FACT-H&N followed by the QLQ-C30 and H&N-Besançon. The French version of FACT-G was internally consistent, and its reproducibility was excellent. FACT-G Physical Well-Being and global scores correlated with all QLQ-C30 subscales. There was evidence of discriminant validity. Compared with the other tools, FACT-G included a statistically significantly higher proportion of items patients considered to be confusing or upsetting. Patients with breast or colorectal cancer expressed a preference for QLQ-C30. Use of the specific H&N additional items increased the responsiveness to change of FACT-G. The French version of FACT-G is valid and has psychometric properties similar to those of FLIC and QLQ-C30.

Shortened irradiation scheme, continuous infusion of 5-fluorouracil and fractionation of mitomycin C in locally advanced anal carcinomas. Results of a phase II study of the European Organization for Research and Treatment of Cancer. Radiotherapy and Gastrointestinal Cooperative Groups.

The European Organization for Research and Treatment of Cancer (EORTC) 22861 randomised trial established that combined radiochemotherapy is the standard treatment for locally advanced anal cancer. This EORTC phase II study (#22953) tests the feasibility of reducing the gap between sequences to 2 weeks, to deliver Mitomycin C (MMC) in each radiotherapy sequence and 5-FU continuously during the treatment. The first sequence consisted of 36 Gy over 4 weeks. 5-FU 200 mg/m(2)/days 1-26, MMC 10 mg/m(2)/day 1 gap 16 days. Then a second sequence of 23.4 Gy over 17 days, 5-FU 200 mg/m(2)/days 1-17 and, MMC 10 mg/m(2)/day 1 was given. 43 patients with a World Health Organization (WHO) status of 0 (n=27) or 1 (n=16) and with T2-T4, N0-3 tumours were included. Compliance with the planned treatment, doses and duration was 93%. The complete response rate was 90.7%. Grade 3 toxicities of 28, 12 and 2% were observed for skin, diarrhoea and haematological toxicities, respectively. The 3-year estimated rates for trials 22861 and 22953 are: 68 and 88% for local control; 72 and 81% for colostomy-free interval, 62 and 84% for severe late toxicity-free interval, and 70 and 81% for survival, respectively. The 22953 scheme is feasible and the results are promising. This is now considered as the new standard scheme by the EORTC.