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The LapOvCa study (ZonMw project number: 171102021), a multicenter randomized study in the Netherlands, showed that a laparoscopy is of additive value to predict the outcome of primary debulking surgery for ovarian cancer patients. Survival is strongly correlated with the size of residual tumor. The aim is to leave no residual tumor or <1cm in maximum diameter of debulking surgeries. If primary debulking surgery seems feasible on clinical and radiological parameters, than start surgery with a diagnostic laparoscopy to see if debulking surgery is feasible with no or <1cm residual tumor. The gynecologic oncologist decides to start with a primary debulking surgery or start with neoadjuvant chemotherapy and interval debulking surgery after three courses of chemotherapy.1

Internationally the guideline is that primary debulking surgery is preferred if there is a high likelihood to no or < 1cm residual disease.2 Our study showed that diagnostic laparoscopy before debulking surgery is useful to predict the outcome. This is also mentioned in the new guideline of Society of Gynecologic Oncology and American Society of Clinical Oncology.2

 

No differences in complications or quality of life were seen between both treatment arms. A disadvantage was seen for the patients who received an unsuccessful surgery with more than 1 cm tumor rest in both treatment arms. Furthermore, we examined the costs of the laparoscopy and compared this with the benefits. By performing a diagnostic laparoscopy in advance, fewer patients received two laparotomies primary and interval debulking surgery, resulting in a reduction of overall costs.

 

The clinical benefit for the individual patient by prevention of an unsuccessful surgery, i.e. futile laparotomy, is the main reason for aiming the national implementation of a laparoscopy to the diagnostic work-up for patients with advanced ovarian cancer. The national guideline in the Netherlands will be adapted.

 

The objective of the project is twofold. The goal is implementation of laparoscopy before a primary debulking surgery in case of advanced stage ovarian cancer if debulking surgery to <1cm seems feasible. Based on this knowledge, we will develop an implementation strategy and evaluate the implementation 2 years later. Since all gynecologic oncology centers are involved in the primary LapOvCa trial and cooperate in the Consortium 2.0, we expect a cooperative attitude to discuss the outcome and a lively discussion on the implementation plans. We will explore the opinions of the introduction of a diagnostic laparoscopy and explore the impeding and enhancing factors for implementation. We will also collaborate with the national guideline committee for ovarian cancer to adjust the national guideline on this topic if there is general commitment or agreement for implementation of a diagnostic laparoscopy.

 

We will perform a budget impact analysis to extrapolate the results of the LapOvCa trial to the national level to estimate the total impact on the number of primary and interval debulking procedures, and the health care budget per annum for the Netherlands. As the economic evaluation demonstrated no great difference in total costs between the two strategies, and changes within the process of care of these patients remain within the same DBC, we expect implementation of initial laparoscopy to have limited impact on the national health care budget. More or less expedited rates of implementing the laparoscopy strategy are thus expected to have limited effect health care costs or budget impact. The proposed budget impact analysis will therefore be straightforward, mainly focusing on patient epidemiology, tempo of implementation, and potential scenarios to further optimize the pathways of care for this population. We will compare the current situation (5% implementation), potential impact (100% implementation) and a most probable rate (80% implementation may be expected). Thereby we will estimate the budget impact per year over a period of four years in the base case analysis, using a medium term perspective where only 6-month health and cost consequences are included (based on the study estimates). The budget impact analysis will allow sensitivity analyses and scenario analysis to evaluate the consequences of various assumptions.

 

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