The overall objective of the study is to assess and describe the transition from open surgery to robotic assisted laparoscopic surgery of early stage endometrial cancer patients with special focus on survival, post-operative complications, and rehabilitation.
Survival and clinical outcome register-data will be stratified on surgical modality and compared.
A prospective cohort study will assess short- and long-term quality of life using validated internationally acclaimed quality of life questionnaires and a pain diary. There will be a specific focus on short term physical rehabilitation.
Since the introduction of robotic assisted laparoscopic surgery an increasing number of patients with endometrial cancer have been operated on with minimal invasive surgery. Immediate advances postoperatively have been noted for this old patient group compared to open surgery. Internationally, this has caused a transition from open surgery to minimal invasive surgery during the past 5-8 years for e.g. endometrial cancer patients.
Several retrospective single-institute studies have reported survival after conventional laparoscopic surgery for endometrial cancer compared to open surgery. Current data indicates that there is no difference regarding survival between laparoscopic and open surgery and there are significant less intra- and immediate postoperative complications associated with laparoscopic surgery. However, evidence is lacking regarding robotic assisted surgery.
In Denmark all clinical and operative data has been collected prospectively for all gynecological cancer patients since 2005 in the Danish Gynecological Cancer Database. There are approximately 600 new cases of endometrial cancer a year and > 80% having localized disease. During the years 2005-2008 most patients were operated on by open surgery. This period was followed by a period (2008-2011) with an increasing number of patients operated on by laparoscopy or robotic assisted laparoscopic surgery. Since 2011 all patients has been operated on with minimal invasive surgery, most of them with robotic assisted laparoscopy.
We hypothesize there is no difference in survival regarding treatment modality (robotic assisted laparoscopic vs. conventional laparoscopic vs. open access surgery for early stage endometrial cancer) and there is a significant benefit regarding short- and long-term complications with minimal invasive surgery.
Self-reported outcome measures represent the most valid way to obtain information on treatment related early and late effects. By asking the patient to assess and grade disease and treatment related effect on e.g. physical functioning bias related to judgment and interpretation from the health care professionals are avoided. The EORTC QLQ C30 is a traditional, standardized questionnaire where all patients are asked the same 30 questions. This way it is easy to compare scores but the questions may not always be optimal and some areas might be measured with less precision than desired.
The computerized adaptive test (CAT) methods are based on item response theory (IRT). Based on a patients previous response a computer program evaluates which question should be answered next until a pre-specified level of precision is reached. This enable a patient reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores across patients.
It has been suggested that following robotic assisted surgery patients return to their daily activities very fast and the rehabilitation period is short.
We believe that physical, psychological, social, sexual and cognitive functioning are important aspects for a cancer patients well-being and her perception of being recovered following a cancer disease. This study will generate valid information on both short- and long-term rehabilitation of early stage endometrial cancer patients operated on by robotic assisted laparoscopic surgery.
Description of the cohort
The register based cohort: Women who are operated on from 2005 to 2013 for FIGO stage I-II endometrial cancer. Both low- and high-risk histology are eligible.
The prospective cohort: women who are operated on by robotic assisted surgery for FIGO stage I-II endometrial cancer from summer 2015 to summer 2016 at Odense and Aalborg University Hospital. Both low- and high-risk histology are eligible. The patients will be recruited during their ambulatory visit prior to the surgery.
Data and biological material
The register based cohort: The national data from January 2005 to December 2012 has been extracted from the Danish Gynecologic Cancer Database. The data will be linked with data from two other national databases (The register of causes of death and the pathology register).
The prospective cohort: We will use the standardised quality of life questionnaire QLQ-C30 and disease specific QLQ-EN24 from the European Organisation for Research and Treatment of Cancer (EORTC). For the QLQ-C30 We will add on the new computerised adaptive test (CAT) methods, that are based on item response theory (IRT) to obtain maximal information. The questionnaires will be asked as a baseline before surgery and after 1, 2 and 3 weeks and again after 1, 3 and 6 months. Furthermore the patients will fill out a pain-diary for the first month. In this diary we will ask the patients to daily rank their level of pain, state where the pain is localized and indicate the consumption of analgesic.