Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study.

BACKGROUND: Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer. METHODS: Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat. DISCUSSION: Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence of strong evidence and despite the possible complications, laparoscopy is already implemented in many countries. We propose a randomized multicentre trial to provide evidence on the effectiveness of laparoscopy before primary surgery for advanced stage ovarian cancer patients. TRIAL REGISTRATION: Netherlands Trial Register number NTR2644.

Age should not be a limiting factor in laparoscopic surgery: a prospective multicenter cohort study on quality of life after laparoscopic hysterectomy.

PURPOSE: A prospective, multicenter cohort study was performed on the implementation of laparoscopic hysterectomy (LH) in the Netherlands. The aim of this study was to evaluate the impact of LH on quality of life (QOL) with respect to age up to 6 months postoperatively. PATIENTS AND METHODS: Women with an indication for LH, either for benign conditions or early-stage low-risk endometrial cancer were included. QOL was measured before and 6 weeks and 6 months after surgery, using the 36-item Short Form Health Survey. Mean QOL values were compared to an unselected, female, Dutch reference population. A longitudinal linear mixed model was applied to assess changes in QOL over time after LH and to determine if in patients ≥65 years of age QOL scores were different. RESULTS: Data on 116 patients were available for analysis. The median age was 54 years at time of surgery (range 34-83) with an interquartile range of 43-65 years. Six months after LH, all QOL values were higher than before surgery and were equal to or higher than those of the reference population. Older women tend to score higher on QOL preoperatively, and these scores remain high postoperatively. CONCLUSION: After LH, QOL improves. Older women report higher QOL values preoperatively and QOL is still high 6 months after the operation. Age does not confer a negative impact on QOL following LH and should not be the reason to refrain from laparoscopic surgery.