Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO) (NCT03580421) | Clinical Trial Compass
CompletedNot Applicable
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)
France77 participantsStarted 2018-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.