Brief Title
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)
Official Title
Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study
Brief Summary
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
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- 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.
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 visits: 1 month after initial surgery
and every 6 months for a total follow-up duration of 12 months 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. The secondary analysis
will use 12-month QALYs. QALYs will be computed at 30 days (primary analysis) and at 1 year
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) and at the end of the observation period
(M12). 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).
Study Type
Interventional
Primary Outcome
the incremental cost-utility ratio
Secondary Outcome
QALYs
Condition
Endometrial Cancer Stage I
Intervention
ambulatory surgery
Study Arms / Comparison Groups
standard pathway group
Description: this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and 3 post-operative consultations (M1, M6, M12) during the first operative year
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
252
Start Date
August 1, 2018
Completion Date
August 1, 2021
Primary Completion Date
August 1, 2021
Eligibility Criteria
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 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 (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, a history of significant lysis of adhesions
during surgery
- Previous lymphadenectomy.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Geoffroy CANLORBE, MD, 1 42 16 24 32, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03580421
Organization ID
P150966
Secondary IDs
2017-A02835-48
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
PSE Hospinnomics
Study Sponsor
Geoffroy CANLORBE, MD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
January 2020