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.

Ropivacaine Wound Infiltration for Pain Management After Breast Cancer Mastectomy: A Population Pharmacokinetic Analysis.

Ropivacaine continuous wound infusions (CWIs) are extensively used as a component of multimodal analgesia. The rational application of CWI of ropivacaine requires a thorough understanding of its pharmacokinetics to investigate the risk of potential systemic toxicity. A population pharmacokinetic (popPK) study was undertaken to describe the pharmacokinetics of ropivacaine CWI during 75 hours. Women undergoing a unilateral mastectomy were scheduled to receive CWI for 40 hours for postoperative analgesia. A 10-mL ropivacaine 0.75% bolus followed by continuous infusion (400 mL of 0.2% ropivacaine at a flow rate of 10 mL/h) was administered via a multihole catheter placed on the major pectoral muscle. PopPK analysis was performed using the nonlinear mixed-effects model. A 1-compartment disposition model with an absorption compartment and a transit compartment for the infusion best describes the data (67 observations from 10 women). Population parameter estimates (between-subject variability, %) are apparent central volume (V/F) 269 L (39.1%), apparent clearance (CL/F) 18.8 h-1 (74.9%), and absorption rate (K12) 0.406 h-1 . The model predicted Cmax as 1.45 ± 0.80 µg/mL, which occurred in the 42.4th hour (39-45.9 hours). This popPK model describes the pharmacokinetics of ropivacaine during continuous wound infusion and confirms the safety profile of the present technique.

The learning curve for the laparoscopic approach to conservative mesorectal excision for rectal cancer: lessons drawn from a single institution's experience.

OBJECTIVES: We aimed to determine the most sensitive markers of the learning process for laparoscopic conservative mesorectal excision (LCME) for rectal cancer to (1) generate a relevant training program for junior surgeons and (2) define appropriate settings for prospective trials. SUMMARY BACKGROUND DATA: The learning process for the laparoscopic approach to treating rectal cancer has not yet been clearly described. METHODS: Over a 42-month period, 127 patients received LCME at our institution. The procedure was performed or supervised by a single referent surgeon. The operative time, conversion to open procedure postoperative morbidity, microscopic margins, and local recurrence were thought to be the most relevant parameters related to the learning process. To give a comprehensive view of success, a single hybrid variable was generated. Curves were drawn using the moving average method for continuous variables and the CUSUM analysis was used for binary variables. RESULTS: A slow but continuous decrease in operative time was observed over all the study period. The overall and surgical morbidities were the most sensitive markers. The conversion rate and R0-resection rate remained stable at 14.9% and 91%, respectively. The overall local recurrence rate was 4.7% at a median follow-up time of 40 months and was not affected by the learning process. The success rate reached a steady state after 50 patients. CONCLUSION: Despite surgeons' early command of the conversion rate, the learning process for LCME affects morbidity for the first 50 patients operated on, but does not adversely affect the oncological results. Much emphasis should therefore be placed on technical training.

Impact of obesity on short-term results of laparoscopic rectal cancer resection.

INTRODUCTION: The influence of obesity [body mass index (BMI) >or= 30 kg/m(2)] on the outcome of laparoscopic colorectal surgery remains controversial. The complexity of rectal laparoscopic resections requires a specific assessment of the impact of obesity on the feasibility and short-term results of the surgery. METHODS: Between February 2002 and May 2007, 210 laparoscopic mesorectal excisions were performed. Demographic, oncologic and perioperative data were entered in a prospective database. Twenty-four patients (11.4%) with BMI over 30 kg/m(2) formed the obese group (OG). The outcomes in the OG and the nonobese group (NOG) were compared. RESULTS: There were significantly more American Society of Anesthesiologists (ASA) score 3 patients (26% in OG versus 9% in NOG; p = 0.03) in the obese group. Obese patients experienced longer operative times (513 min in OG vs. 421 min in NOG; p < 0.01) and more frequent conversion to laparotomy (46% in OG vs. 12% in NOG; p < 0.001). Morbidity grade 1 was higher in the obese group (29.2% vs. 9.7% in NOG; p = 0.01), but there was no difference in regards to morbidity grade 2 or more (33.3% in OG vs. 32.3% in NOG). In addition, conversion to laparotomy among the obese did not increase significantly morbidity grade 2 or higher (5 of 11 for OG converted vs. 3 of 13 for OG nonconverted; p = 0.39). Regarding the oncological parameters (e.g. number of lymph nodes removed, distal and lateral margins) there was no difference between groups. CONCLUSION: Obesity increases operative duration and conversion rate of rectal laparoscopic resection for cancer. Although obesity is associated with a worse preoperative evaluation, there is no increase in relevant morbidity and no impairment of oncological safety.