NCT03580421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

3.9 years

First QC Date

June 6, 2018

Last Update Submit

December 10, 2022

Conditions

Endometrial Cancer Stage IEndometrial Cancer Stage II

Keywords

Endometrial CancerHealth-economics analysisAmbulatory surgeryQALYdiscrete choice experiment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • QALYs

    1 month

  • Incidence of Treatment-Emergent Adverse events

    1 month

  • Success rate of ambulatory surgery

    1 month

  • preferences about ambulatory care pathways

    inclusion

Study Arms (2)

standard pathway group

ACTIVE COMPARATOR

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

ambulatory pathway group

EXPERIMENTAL

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

Interventions

ambulatory surgeryPROCEDURE

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

ambulatory pathway group
standard surgeryPROCEDURE

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

standard pathway group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de Chirurgie Gynécologique Obstétrique Reproduction Humaine

Clermont-Ferrand, 63003, France

Location

CHIC - Gynécologie-Obstétrique-Maternité

Créteil, 94010, France

Location

Service de chirurgie gynécologique, Centre de lutte contre le cancer

Dijon, France

Location

Service de chirurgie gynécologique, Centre Hospitalier Simone Veil

Eaubonne, 95600, France

Location

Service de chirurgie gynécologique, hôpital Pitié-salpêtrière

Paris, 75013, France

Location

HEGP - Chirurgie Cancérologique Gynécologique et du Sein

Paris, 75015, France

Location

Hôpital Bichat-Claude Bernard Gynécologie obstétrique

Paris, 75018, France

Location

Service de chirurgie gynécologique, hôpital Tenon

Paris, 75, France

Location

IGR - Comité d'Oncologie Gynécologique

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Ambulatory Surgical Procedures

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Geoffroy CANLORBE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Lise ROCHAIX, MD PHD

    Hospinnomics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a multicentre, prospective and randomised study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 9, 2018

Study Start

August 1, 2018

Primary Completion

June 14, 2022

Study Completion

June 14, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Locations

FR(9)