The Influence of Surgical Complexity and Center Experience on Postoperative Morbidity After Minimally Invasive Surgery in Gynecologic Oncology: Lessons Learned from the ROBOGYN-1004 Trial.

BACKGROUND: This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology. METHODS: The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery. RESULTS: This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL (p = 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06-2.47; p = 0.027) and according to the type of surgery (p < 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0-11; p = 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38-1.99; p = 0.75). CONCLUSION: The findings suggest that the center's experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures.

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.

[The impact of conversational hypnosis on the pre- and postoperative anxiety of patients in gynecological surgery versus ordinary practice: A comparative study]. / L'impact de l'hypnose conversationnelle sur l'anxiété pré et post opératoire des patientes en chirurgie gynécologique versus pratique courante : étude comparative.

Hysterectomies are often linked to benign pathologies, but they are nevertheless the cause of anxiety and lead to significant physiological and psychological changes for these women. The uterus, as a symbol of femininity for women, has a unique meaning in relation to its reproductive function and its role in sexuality. Given this fact, does conversational hypnosis-used when a patient arrives at the hospital-have an impact on the pre- and postoperative anxiety of patients hospitalized for gynecological surgery in the form of a hysterectomy? To answer this question, a pilot study of comparative monocentric feasibility was performed with two parallel groups of 10 patients in 2014. The first group was received using ordinary practices, while the second group was received using techniques of conversational hypnosis. The main objective of this study was to estimate the effect of the use of conversational hypnosis upon reception compared to the use of the ordinary care protocol on perioperative anxiety upon reception, measured on the Visual Analog Scale (VAS) of anxiety for patients undergoing a hysterectomy associated with a benign pathology.The results show that patients who received the techniques of conversational hypnosis upon reception to the hospital had clearly lower pre- and postoperative anxiety.The results of this pilot feasibility study made it possible to perform follow-up research to confirm these first results in the context of a call for projects by SIRIC BRIO (Call for projects 2016: Site de Recherche Intégrée en Cancérologie - Bordeaux Recherche Intégrée en Oncologie). This research is currently underway to examine the impact of a formal preoperative hypnosis session on the perioperative anxiety of patients hospitalized for hysterectomy related to pelvic gynecologic cancer.

Modified Gluteal Fold V-Y Advancement Flap for Reconstruction After Radical Vulvectomy.

OBJECTIVE: To describe the surgical technique of the V-Y cutaneous supra-fascial (modified) gluteal advancement flaps for reconstruction after radical vulvectomy and to assess the outcome of patients according to their clinical characteristics. METHODS: Between January 2006 and July 2012, 36 V-Y flaps were performed in 21 patients to cover the defect after radical surgery of primary vulvar cancers. Surgery duration, blood loss, hospital stay, and wound healing were assessed according to patient age, body mass index (BMI), American Society of Anesthesiologists (ASA) score, and the initial defect size. RESULTS: Median patient age, BMI, and ASA score were 80 (range, 31-91), 28 (range, 18-36), 3 (range, 1-3), respectively. Median surgery duration and blood loss were 180 minutes (range, 60-275) and 400 mL (range, 100-1000), respectively. Median operating time was higher in patients ASA3 than ASA less than 3, 200 versus 120 minutes (P = 0.038). Median initial defect size was higher in patients with BMI greater than 28 than 28 or less, 92 versus 55 cm (P = 0.004). Local scar defect was observed in 16 patients (76%), mild, less than 10 cm in 10 patients. Median wound healing duration was higher in patients with bilateral than unilateral flap, 16 versus 9.5 days (P = 0.034). CONCLUSIONS: The V-Y cutaneous suprafascial gluteal advancement flap for vulvar reconstruction after vulvectomy is an easy, safe, and reliable procedure. However, even mild local scar defect after bilateral flap may impact on wound healing and hospital stay, in elderly and ASA3 patients.

Robotically assisted para-aortic lymphadenectomy: surgical results: a cohort study of 487 patients.

OBJECTIVES: The aim of this study was to evaluate perioperative outcomes of robotic-assisted laparoscopic para-aortic lymphadenectomy (PAL) in patients with gynecologic cancers during the learning phases of robotic surgery programs and to compare results of extraperitoneal versus transperitoneal approaches of PAL. MATERIALS AND METHODS: This study is a retrospective multicentric study of patients who underwent robotically assisted laparoscopic PAL (N = 487). Eleven European centers and 1 US center participated in the study. Abstracted data included age, body mass index, indication, type of surgical approach (transperitoneal or extraperitoneal), associated surgical procedures, operative time, estimated blood loss, lymph node count, hospital length of stay (LOS), and complications. Para-aortic lymphadenectomy was performed by an extraperitoneal approach in 58 cases (12%) and transperitoneal in 429 cases (88%). RESULTS: The mean (SD) para-aortic lymph node count was 12.6 (8.1), operative time was 217 (85) minutes, estimated blood loss was 105 (110) mL, and LOS was 2.8 (3.2) days. Four (0.8%) conversions to open and 2 (0.4%) conversions to laparoscopy were described. There were 32 lymphocysts (6.6%), 3 deep venous thromboses (0.6%), and 10 transfusions (2.1%). For transperitoneal approach, the average number of lymph nodes removed was higher in isolated PAL group than the hysterectomy combined group (report node counts 95% confidence interval, -7.29 to -3.52, P = 1.5 × 10⁻6). For isolated PAL, the LOS was shorter in the extraperitoneal group than in the transperitoneal group (report data 95% CI, -1.35 to -0.35, P = 0.001). CONCLUSIONS: Robotic-assisted PAL seems safe and feasible. More lymph nodes were removed during an isolated transperitoneal PAL dissection compared with a combined procedure with hysterectomy. Extraperitoneal approach seems attractive relative to transperitoneal dissection, but the superiority of one or the other way is not demonstrated by our study.

[Oncofertility and breast cancer: Where have we come from, where are we going?]. / Oncofertilité du cancer du sein : d'où vient-on, où allons-nous ?

BACKGROUND: Focusing on the current context of national and international recommendations, techniques development to evaluate and preserve fertility and patients' claims, this study aims to make a survey about the management of patients' breast cancer regarding oncofertility. METHODS: Retrospective and analytic study of medical practices at Bergonié Institute of health professionals (medical oncologists, surgical oncologists, nurses) dedicated to the care of non-disseminated breast cancer patients younger than 37, needing medical treatment. RESULTS: The number of participants was 230. The most interested practitioners in fertility theme are those of multidisciplinary consultation and surgeons (P<0.001), with an increasing interest during last years (P<0.05). The information about hypofertilizing risks of treatments are delivered most of the time by oncologists (57.7%). The motherhood project is expressed by 11 patients (4.9%) before treatment, only 4 of them receive information on the risks and 49 patients (21.7%) during follow-up. Only 24 patients (48% of the 49) are encouraged for motherhood. CONCLUSION: To satisfy patients' requests, several improvements have to be made regarding the patients' information, the health professionals' awareness and care coordination.