Rutten et al. BMC Cancer 2012, 12:31 http://www.biomedcentral.com/1471-2407/12/31 S T U D Y P R O T O C O L Open Access Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study Marianne J Rutten1*, Katja N Gaarenstroom2, Toon Van Gorp3, Hannah S van Meurs1, Henriette JG Arts4, Patrick M Bossuyt5, Henk G Ter Brugge6, Ralph HM Hermans7, Brent C Opmeer8, Johanna MA Pijnenborg9, Henk WR Schreuder10, Eltjo MJ Schutter11, Anje M Spijkerboer12, Celesta WM Wensveen13, Petra Zusterzeel14, Ben Willem J Mol1, Gemma G Kenter1 and Marrije R Buist1 Abstract 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 * Correspondence: m.j.rutten@amc.uva.nl 1Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands Full list of author information is available at the end of the article © 2012 Rutten et al; BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.