Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial.

OBJECTIVE: In gynecologic oncology, minimally invasive surgery using conventional laparoscopy (CL) decreases the incidence of severe morbidity compared to open surgery. In 2005, robot-assisted laparoscopy (RL) was approved for use in gynecology in the US. This study aimed to assess whether RL is superior to CL in terms of morbidity incidence. METHODS: ROBOGYN-1004 (ClinicalTrials.gov, NCT01247779) was a multicenter, phase III, superiority randomized trial that compared RL and CL in patients with gynecologic cancer requiring minimally invasive surgery. Patients were recruited between 2010 and 2015. The primary endpoint was incidence of severe perioperative morbidity (severe complications during or 6 months after surgery). RESULTS: Overall, 369 of 385 patients were included in the as-treated analysis: 176 and 193 underwent RL and CL, respectively. The median operating time for RL was 190 (range, 75-432) minutes and for CL was 145 (33-407) minutes (p < 0.001). The blood loss volumes for the corresponding procedures were 100 (0-2500) and 50 (0-1000) mL (p = 0.003), respectively. The overall rates of conversion to open surgery for the corresponding procedures were 7% (10/176) and 5% (10/193), respectively (p = 0.52). Severe perioperative morbidity occurred in 28% (49/176) and 21% (41/192) of patients who underwent RL and CL, respectively (p = 0.15). At a median follow-up of 25.1 months (range, 0.6-78.2), no significant differences in overall and disease-free survival were observed between the groups. CONCLUSIONS: RL was not found superior to CL with regard to the incidence of severe perioperative morbidity in patients with gynecologic cancer. In addition, RL involved a longer operating time than CL.

Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-Related Pain: The EQUIMETH2 Trial (Methadone for Cancer-Related Pain).

CONTEXT: In the European Association for Palliative Care recommendations for cancer pain management, there was no consensus regarding the indications, titration, or monitoring of methadone. OBJECTIVES: This national, randomized, multicenter trial aimed to compare two methadone titration methods (stop-and-go vs. progressive) in patients with cancer-related pain who were inadequately relieved by or intolerant to Level 3 opioids. METHODS: The primary end point was the rate of success/failure at Day 4, defined as pain relief (reduction of at least two points on the visual scale and a pain score <5 for two consecutive days) and no overdose (Rudkin scale ≥3 and respiratory rate <8/minute). The patients were followed for two months after enrollment. RESULTS: The cancer-related pain characteristics of the 146 patients were as follows: 16% were nociceptive, 85% experienced breakthrough pain, and 84% had mixed types of pain. The reasons for switching to methadone were a lack of efficacy that was either isolated (56%) or associated with intolerance (38%). Adequate pain relief was obtained in 80% of the patients (median of three days in both groups [P = 0.12]) and lasted until D56. The rate of success/failure was approximately 40% at Day 4 in both groups, with overdoses in 13% of the patients throughout the study. The two methods were considered equally easy to perform by nearly 60% of the clinicians. CONCLUSION: Methadone is an effective and sustainable second-line alternative opioid for the treatment of cancer-related pain. The methods of titration are comparable in terms of efficacy, safety, and ease of use.

Reasons for encounter in young people consulting a family doctor in the French speaking part of Switzerland: a cross sectional study.

BACKGROUND: Knowledge of patient's reasons for encounter is useful to inform health service planning and health professional education. Our aim was to describe reasons for encounter as stated by an unselected group of young people attending primary care practices in the French-speaking part of Switzerland. METHODS: Consecutive patients aged between 15 and 24 years were recruited as part of the PRISM-Ado trial (n = 594). They completed an anonymous questionnaire in the waiting room, including their main reason for encounter (free text). Reasons for encounter were coded using ICPC-2 classification and analyzed according to sex, age and living in a rural or urban area. RESULTS: 95 % of questionnaires contained valid data about reasons for encounter (n = 567). General and unspecific (A) reasons were the most common in boys (44 %) and girls (42 %), followed by respiratory, musculoskeletal, dermatological and psychological reasons. Psychological reasons were more frequent in girls attending urban practices; musculoskeletal and dermatological reasons were more frequent in rural areas. Sexually transmitted infections or substance use were very rarely stated as a reason for encounter. CONCLUSIONS: This is the first study describing reasons for encounter as stated by young people themselves in primary care in Switzerland. These findings provide useful guidance for family doctors training and health service planning in Europe. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12608000432314 .

Excessive substance use among young people consulting family doctors: a cross-sectional study.

BACKGROUND: Family doctors can only play a role in the prevention of excessive substance use in young people if those affected are seen in the practice. OBJECTIVE: To describe the prevalence of excessive substance use among young people consulting family doctors in a European context. METHODS: As part of a trial of an intervention addressing substance use we collected data from young people consulting 32 family doctors in the French-speaking part of Switzerland. Before the consultation, consecutive patients aged 15-24 years completed a self-administered questionnaire on their general health and substance use. Outcomes were excessive alcohol (defined as ≥1 episode of binge drinking), excessive cannabis (use ≥1/week), regular tobacco (≥1 cigarettes a day) and/or any other substance use in the past 30 days. Prevalence data were computed with 95% confidence intervals (CIs) adjusted for clustering within practices, stratified by age and gender. RESULTS: Between February 2009 and November 2010, 636 patients were eligible. Participation rate was 93.4% (n=594, 53% female). The prevalence of excessive use in the past 30 days was alcohol 44.9% (95% CI: 37.8-52.1), cannabis 11.1% (95% CI: 8.0-14.1), tobacco 23.4% (95% CI: 19.0-28.1) and any other drug 2.6 (95% CI: 1.4-4.2). Excessive use was higher in males than in females. Except for tobacco prevalence of excessive use was only slightly higher in young adults compared to adolescents. CONCLUSION: Excessive substance use is frequent among young people consulting family doctors in a European context. Future research should provide guidance about how to best seize this window of opportunity for prevention and early intervention.

Effectiveness of training family physicians to deliver a brief intervention to address excessive substance use among young patients: a cluster randomized controlled trial.

BACKGROUND: Brief interventions delivered by family physicians to address excessive alcohol use among adult patients are effective. We conducted a study to determine whether such an intervention would be similarly effective in reducing binge drinking and excessive cannabis use among young people. METHODS: We conducted a cluster randomized controlled trial involving 33 family physicians in Switzerland. Physicians in the intervention group received training in delivering a brief intervention to young people during the consultation in addition to usual care. Physicians in the control group delivered usual care only. Consecutive patients aged 15-24 years were recruited from each practice and, before the consultation, completed a confidential questionnaire about their general health and substance use. Patients were followed up at 3, 6 and 12 months after the consultation. The primary outcome measure was self-reported excessive substance use (≥ 1 episode of binge drinking, or ≥ 1 joint of cannabis per week, or both) in the past 30 days. RESULTS: Of the 33 participating physicians, 17 were randomly allocated to the intervention group and 16 to the control group. Of the 594 participating patients, 279 (47.0%) identified themselves as binge drinkers or excessive cannabis users, or both, at baseline. Excessive substance use did not differ significantly between patients whose physicians were in the intervention group and those whose physicians were in the control group at any of the follow-up points (odds ratio [OR] and 95% confidence interval [CI] at 3 months: 0.9 [0.6-1.4]; at 6 mo: 1.0 [0.6-1.6]; and at 12 mo: 1.1 [0.7-1.8]). The differences between groups were also nonsignificant after we restricted the analysis to patients who reported excessive substance use at baseline (OR 1.6, 95% CI 0.9-2.8, at 3 mo; OR 1.7, 95% CI 0.9-3.2, at 6 mo; and OR 1.9, 95% CI 0.9-4.0, at 12 mo). INTERPRETATION: Training family physicians to use a brief intervention to address excessive substance use among young people was not effective in reducing binge drinking and excessive cannabis use in this patient population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, no. ACTRN12608000432314.

Brief intervention addressing excessive cannabis use in young people consulting their GP: a pilot study.

BACKGROUND: When excessive cannabis consumption occurs in adolescence, the adverse consequences extend into adulthood. Interventions by GPs are effective in preventing harm associated with alcohol use. Similar interventions have potential in addressing cannabis use. AIM: To develop and pilot test a brief intervention targeting excessive cannabis use (defined as > or = 1x/week) in young people in primary care. DESIGN OF THE STUDY: Pilot intervention trial. SETTING: Seven family practices in Switzerland. METHOD: The team collaborated with GPs and young people to develop the intervention. Seven GPs piloted its use in their consultations. Patients aged 15 to 24 years consulting for any health problem were recruited before the consultation. Cannabis use, other substance use, and their psychosocial correlates were assessed with a short confidential questionnaire administered before the consultation and 1 month later. GPs, staff, and patients were asked to comment on the study and its feasibility. RESULTS: Of 81 young people invited to participate, 78 (70% female) agreed (participation rate: 96%). One in seven (13.2%, 95% confidence interval = 7.5% to 18.9%) used cannabis at least once a week. Data at 1 month were available for 42% who had provided email contact details and 91% of those who had provided their mobile phone number (63% overall). In most cases, the intervention lasted no more than 5 minutes. Comments from participants added favourable data towards the feasibility of the study. CONCLUSION: This pilot study provides a solid base on which to build a randomised trial of a brief intervention addressing cannabis use in young people consulting in family practice.

Prevention of surgical site infection after breast cancer surgery by targeted prophylaxis antibiotic in patients at high risk of surgical site infection.

OBJECTIVE: We previously showed that previous chemotherapy and immediate breast reconstruction were associated with an increased risk of surgical site infection (SSI) in patients undergoing breast cancer surgery. The present before-after study evaluated a preventive strategy for high-risk patients. PATIENTS AND METHODS: We compared the incidence of SSI in two prospective observational cohorts of patients underwent clean procedure in curative intent for a-biopsy proven breast cancer: a historical cohort followed before implementation of a preventive strategy and a second cohort followed thereafter. The strategy consisted of identifying patients at risk of SSI and prophylaxis administration of cefuroxime to those patients. The impact of our strategy was analyzed using a logistic regression model adjusted for potential confounders. RESULTS: SSI incidence was estimated at 19/542 (3.5%) before preventive strategy versus 2/247 (0.8%) thereafter (crude odds ratio (OR) 0.22 confidence interval [95% CI 0.05-0.97], P = 0.03). After adjustment for confounders (breast reconstruction, previous breast surgery, and duration of surgery), our preventive strategy reduced the risk of SSI by 81% (adjusted OR 0.19 [95% CI 0.04-0.85], P = 0.03). CONCLUSION: These results showed that antibiotic prophylaxis is beneficial for patients at high-risk of WI after breast cancer surgery. Randomized controlled trials should now confirm these findings.

A simple predictive model for postoperative mortality after head and neck cancer surgery with opening of mucosa.

The aim of this study was to determine the risk factors for the mortality during the first 30 days after a major head and neck cancer surgery. Two hundred and sixty one consecutive surgical procedure were prospectively studied at Oscar Lambret Cancer Centre within a 36-months period. Twenty variables were recorded for each patient. The significant risk factors for postoperative mortality were assessed by univariate and multivariate analysis. Overall 30-days mortality rate was 3.83% [95% CI 3.13-4.53]. In univariate analysis identified four risk factors: female gender (odd ratio 4.25 [95% CI 1.03-17.56]), age equal or superior than 70 (odd ratio 5.06 [95% CI 1.35-18.36]), current alcohol addiction (odd ratio 3.65 [1.02-13.06]) and laryngeal location (odd ratio 4.23 [CI 95% 1.18-3.38]). In multivariate analysis only female gender and laryngeal location remained significant. The incidence of postoperative mortality was 1.63% for patients without risk factor and was 6.41% for those with one or two risk factors. This model identifies easily high-risk patients for major head and neck cancer surgery. A multicenter validation is necessary.

[Endometrial cancer by laparoscopy and vaginal approach in the obese patient]. / La voie d'abord chirurgicale coeliovaginale chez les patientes obèses atteintes d'un cancer de l'endomètre.

To prove feasibility of laparoscopic and vaginal surgical approach in obese patients with endometrial cancer, 81 patients were included retrospectively in 2 Cancer Centres : 41 obese and 40 non obese. We performed hysterectomy with oophorectomy and pelvic lymphadenectomy by laparoscopic and vaginal approach. Operative time was higher for obese patients vs non obese (150 vs 121 minutes, p = 0.01) but pelvic nodes (16.3 vs 16.2), postoperative stay (3.8 [2-8] vs 3.6 days [2-7]), complications and disease-free survival (93 % vs 83 %) were similar. Matching 41 obese patients treated by laparoscopy with 29 obese patients with endometrial cancer treated by laparotomy, hospital stay was shorter in the laparoscopic group (3.8 [2-8] vs 7.4 days [5-10] p < 0.001) and pelvic nodes (16.3 [3-50] vs 11.5 [2-34]), operative time (149.9 [80-300] vs 167.9 minutes [60-390]) and disease-free survival (93 vs 80 %) were similar. One patient treated by laparotomy never received intended radiotherapy because of a delay greater than 3 months caused by cutaneous necrosis. For obese patients with stage I endometrial adenocarcinoma, laparoscopic approach should be first choice because of similar operative complications and pelvic nodes, shorter hospital stay and less abdominal wall morbidity associated with lower risk to delay adjuvant radiotherapy.

Multivariate analysis of risk factors for wound infection in head and neck squamous cell carcinoma surgery with opening of mucosa. Study of 260 surgical procedures.

The goal of this prospective study was to determine risk factors for wound infections (WI) for patients with head and neck cancer who had undergone surgical procedures with opening of upper aerodigestive tract mucosa in multimodal therapeutic approaches. Two hundred and sixty consecutive surgical procedures were studied at Oscar Lambret Cancer Center over a 36-month period. Twenty-five variables were recorded for each patient. Statistical evaluation used chi2 test analysis (categorical data) and Mann-Whitney test (continuous variables). Multivariate analysis was performed with logistic regression model. The overall rate of WI was 45% (117/260). Univariate analysis indicated that five variables were significantly related to the likelihood of WI: male sex (p = 0.03), previous chemotherapy (p = 0.009), duration of previous hospital stay (p = 0.013), hypopharyngeal location (p = 0.003), post-laryngectomy tracheostoma (p < 0.001). Multivariate analysis identified only one major risk factor for WI: post-laryngectomy tracheostoma (Odd Ratio 1.9 [95% CI 1.3-3]; 33% versus 64%; p = 0.001). Despite antibiotic prophylaxis, WI occurrence is high. This study identified one major risk factor, post-laryngectomy tracheostomy. Long-term curative antibiotherapy must be evaluated in cancer head and neck surgery requiring post-laryngectomy tracheostoma.

Prognostic significance of wound infections following major head and neck cancer surgery: an open non-comparative prospective study.

OBJECTIVE: We evaluated the incidence, risk factors and consequences of wound infection (WI) following major head and neck cancer surgery in an open non-comparative study. PATIENTS AND METHODS: The study group, comprising 95 patients who underwent clean-contaminated procedures with opening of the upper aerodigestive tract for biopsy-proven squamous cell cancer, were studied over a 1-year period. Antibiotic prophylaxis was amoxicillin and clavulanic acid. More than 20 variables were prospectively recorded for each patient. The mean follow-up was 30 months. MAIN RESULTS: The overall WI rate was 50.5% (48/95). Most pathogens isolated from samples were gram-negative rods. In univariate analysis, we found three risk factors for WI: alcohol consumption (P = 0.07), a hypopharyngeal location (P = 0.02) and laryngectomy stoma (P = 0.01). WI were associated with postoperative fever (P = l.5 x 10(-11)), postoperative antibiotic therapy (P = 1.5 x 10(-5)) and postoperative death (P = 0.043). Patients without WI had a median postoperative hospital stay of 15 days compared with 29 days for those with WI (P < 0.001). Healing of WI was achieved after a median time of 48 days. WI delayed postoperative radiation therapy in 21 out of 33 evaluable patients. But overall survival, and local and metastatic failures were similar with and without WI. CONCLUSIONS: WI are associated with a heavy postoperative morbidity, but have no prognostic impact on cancer control.

Previous chemotherapy as a predictor of wound infections in nonmajor head and neck surgery: Results of a prospective study.

BACKGROUND: The goal of this prospective study was to determine the incidence of wound infections (WI) after clean uncontaminated head and neck cancer procedures and after emergency tracheotomies. METHODS: Two hundred twelve clean procedures without tracheotomy or opening of mucosa (neck dissections, large skin resections, thyroidectomies, parotid gland resections, and explorative cervicotomies) were studied at Oscar Lambret Cancer Center over a 24-month period. RESULTS: WI rate was 6.6% (14 of 212). In a univariate analysis, only one variable was significantly related to the likelihood of WI: previous anticancer chemotherapy. All but one patient who had had previous chemotherapy demonstrated WI (14 of 15). CONCLUSIONS: After previous chemotherapy, WI rate in clean uncontaminated head and neck surgery was as high as 90%. In this case, antibiotic prophylaxis should be evaluated.