Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)

Study Overview
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Brief Summary
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To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed. The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life. The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer. A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

Detailed Description
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In developed countries, endometrial cancer is the fourth most common cancer in women. Women with stage I disease, representing almost 75% of cases, have an overall survival of 95%. According to the European guidelines, the standard surgical approach for stage I endometrial cancer consists of laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy. For patients undergoing laparoscopic surgery for gynecological malignancies, most studies report average hospital stays of 1 day after surgery. Patients are commonly kept in the hospital following surgery for pain and nausea control, prolonged bladder catheterization, and observation for surgical complications. However, some recent retrospective studies show that same-day discharge for patients undergoing laparoscopic staging for endometrial cancer is feasible and safe, despite associated comorbidities (i.e., obesity, hypertension, diabetes) related to endometrial cancer. A short hospital stay decreases the risk of exposure to hospital infections, causes less disruption to the patient's personal life, results in potential cost savings for patients and relatives, as well as for hospitals, and there is positive feedback regarding the social environment of patients as they return rapidly to daily activities and work. To date, safety, feasibility and cost-utility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed. The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life. The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer. A total of 252 consecutive, eligible, consenting patients with a low, intermediate- and high-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway. Preoperative and postoperative protocols (including geriatric and dietetic evaluation, and anesthesia and nursing consultation) will be applied for optimizing same-day discharge of patients randomly assigned to ambulatory surgery. Data will be collected in conjunction with usual care visit, 1 month after initial surgery. The economic evaluation will closely follow the 2011 French National Authority for Health (HAS) economic evaluation guidelines and the evaluation proposal will have three complementary parts with a full cooperation between those involved in the evaluation: First, the economic evaluation will focus on evaluating the cost-utility profile of ambulatory surgery in endometrial cancer in France. This economic evaluation will include a micro-costing study to estimate by direct observation the cost of resources used during the ambulatory pathway, and the total cost of patients' care in each group. The primary endpoint will be the incremental cost-utility ratio using the 30-day health related quality of life. It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights. QALYs will be computed at 30 days (primary analysis) using both mortality and HRQoL scores. Second, the investigators will perform an analysis of patients' and professionals' preferences about ambulatory care pathways. These preferences will be analyzed in depth, using both surveys and recent tools developed in experimental economics. Health care professionals' views and preferences will be collected, using questionnaires and face-to-face interviews both at the beginning of the study (M0). Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics. Third, a thorough analysis of the ethical and inequality aspects tied to the development of ambulatory surgery in endometrial cancer will be developed, following the methodological guidance issued in 2013 by the HAS. Special emphasis will be laid on equity issues in the measurement of patients' benefits, using a capability approach (ICECAP-A questionnaire). Finally, another secondary objective will be to assess the safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer, and to validate biomarkers of high risk of nodal involvement in a translational study (complementary budget will be asked for this part).

Official Title
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Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

Conditions
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Endometrial Cancer Stage I, Endometrial Cancer Stage II

Intervention / Treatment
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* Procedure: ambulatory surgery
* Procedure: standard surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 18 years of age Women affiliated to the social security (including CMU) Women understanding the French language Women with preoperative endometrial biopsy and preoperative MRI to assess disease stage Women with stage I or II endometrial cancer according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) classification Women eligible for surgery including laparoscopic or vaginal total hysterectomy and bilateral salpingo-oophorectomy with or without nodal staging (i.e., sentinel lymph node biopsy +/- pelvic lymphadenectomy) informed consent signed pregnant or breast-feeding patient Exclusion Criteria: Nonclinical stage I uterine malignancy Women eligible for surgery including nodal staging with para-aortic lymphadenectomy Significantly enlarged uterus that prevent intact vaginal removal or will require a laparotomy which may limit ambulatory management (uterine size larger than 10 weeks of gestation) Cardiovascular disease (including participants with pacemakers), pulmonary disease Estimated life expectancy less than 12 months Medically unfit for surgery Patient unfit to complete questionnaire A history of conversion to laparotomy for lysis of adhésions or significant lysis of adhesions during a surgery Previous lymphadenectomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a multicentre, prospective and randomised study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard pathway group<br>this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and most of the time 3 post-operative consultations (M1, M6, M12) during the first operative year | Procedure: standard surgery<br>* total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy<br>|
| Experimental: ambulatory pathway group<br>Preoperative and postoperative protocols will be applied for optimizing same-day discharge. Gynaecologists, anaesthetists, and nursing staff will work as a team. A specific anesthesia consultation will focus on ambulatory surgery management. A geriatric evaluation will be offered to women over 70 years old with a score ≤14 according to G8 screening tool. A dietetic evaluation will be offered to women with BMI ≥ 35. A nursing consultation will be offered, as patient and their family preparation prior to ambulatory surgery is important. | Procedure: ambulatory surgery<br>* total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incremental cost-utility ratio | It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QALYs | QALYs will be computed using both mortality and HRQoL scores | 1 month | 
| Incidence of Treatment-Emergent Adverse events | number of severe adverse events | 1 month | 
| Success rate of ambulatory surgery | Rate of women requiring overnight admission | 1 month | 
| preferences about ambulatory care pathways | Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics. | inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Cancer, Health-economics analysis, Ambulatory surgery, QALY, discrete choice experiment