MedTrace Logo

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

NCT03580421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2022-12-13

No results posted yet for this study

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.

Conditions

  • Endometrial Cancer Stage I
  • Endometrial Cancer Stage II

Interventions

PROCEDURE

ambulatory surgery

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

PROCEDURE

standard surgery

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

Sponsors & Collaborators

  • Ecole d'econmie de Paris (PSE)-Hospinnomics

    collaborator UNKNOWN

  • Université Montpellier

    collaborator OTHER

  • Université de Rennes 1 CREM CNRS UMR 6211

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Geoffroy CANLORBE, MD · Assistance Publique - Hôpitaux de Paris

  • Lise ROCHAIX, MD PHD · Hospinnomics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-06-14
Completion
2022-06-14

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03580421 on ClinicalTrials.gov