Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03580421 |
| Other study ID # |
P150966 |
| Secondary ID |
2017-A02835-48 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2018 |
| Est. completion date |
June 14, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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, 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).
