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

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ClinicalTrials.gov Identifier: NCT03580421
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : November 22, 2021
Sponsor:
Collaborators:
Ecole d'econmie de Paris (PSE)-Hospinnomics
Université Montpellier
Université de Rennes 1 CREM CNRS UMR 6211
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Endometrial Cancer Stage I Endometrial Cancer Stage II Procedure: ambulatory surgery Procedure: standard surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a multicentre, prospective and randomised study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Arm Intervention/treatment
Active Comparator: standard pathway group
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
total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

Experimental: ambulatory pathway group
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
total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy




Primary Outcome Measures :
  1. the incremental cost-utility ratio [ Time Frame: 1 month ]
    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


Secondary Outcome Measures :
  1. QALYs [ Time Frame: 1 month ]
    QALYs will be computed using both mortality and HRQoL scores

  2. Incidence of Treatment-Emergent Adverse events [ Time Frame: 1 month ]
    number of severe adverse events

  3. Success rate of ambulatory surgery [ Time Frame: 1 month ]
    Rate of women requiring overnight admission

  4. preferences about ambulatory care pathways [ Time Frame: inclusion ]
    Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580421


Contacts
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Contact: Geoffroy CANLORBE, MD 1 42 17 81 11 ext +33 geoffroy.canlorbe@aphp.fr
Contact: Anne BISSERY, MD 1 42 16 24 32 ext +33 anne.bissery@aphp.fr

Locations
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France
Service de Chirurgie Gynécologique Obstétrique Reproduction Humaine Active, not recruiting
Clermont-Ferrand, France, 63003
CHIC - Gynécologie-Obstétrique-Maternité Recruiting
Créteil, France, 94010
Contact: Bassam HADDAD, Pr    1 45 17 55 43 ext +33    bassam.haddad@chicreteil.fr   
Contact: Anne BISSERY, MD    1 42 16 24 32 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Bassam HADDAD, Pr         
Service de chirurgie gynécologique, Centre de lutte contre le cancer Recruiting
Dijon, France
Contact: Clémentine JANKOWSKI, MD    3 80 73 75 08 ext +33    CJankowski@cgfl.fr   
Contact: Anne BISSERY, MD    142162432 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Clementine JANKOWSKI, MD-PhD         
Service de chirurgie gynécologique, Centre Hospitalier Simone Veil Recruiting
Eaubonne, France, 95600
Contact: Vincent VILLEFRANQUE, MD    1 34 06 60 00 ext +33    vincent.villefranque@ch-simoneveil.fr   
Contact: Anne BISSERY, MD    142162432 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Vincent VILLEFRANQUE, MD         
Service de chirurgie gynécologique, hôpital Pitié-salpêtrière Recruiting
Paris, France, 75013
Contact: Geoffroy CANLORBE    1 42 17 81 11 ext +33    geoffroy.canlorbe@aphp.fr   
Contact: Anne Bissery, MD    142162432 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Geoffroy Canlorbe, MD-PhD         
HEGP - Chirurgie Cancérologique Gynécologique et du Sein Recruiting
Paris, France, 75015
Contact: Anne Sophie BATS, Pr    1 56 09 35 84 ext +33    anne-sophie.bats@aphp.fr   
Contact: Anne BISSERY, MD    1 42 16 24 32 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Anne-sophie BATS, Pr         
Hôpital Bichat-Claude Bernard Gynécologie obstétrique Recruiting
Paris, France, 75018
Contact: Martin KOSKAS, Pr    1 40 25 76 93 ext +33    martin.koskas@aphp.fr   
Contact: Anne BISSERY, MD    1 42 16 24 32 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Martin KOSKAS, Pr         
Service de chirurgie gynécologique, hôpital Tenon Active, not recruiting
Paris, France, 75
IGR - Comité d'Oncologie Gynécologique Recruiting
Villejuif, France, 94805
Contact: Amandine MAULARD, MD    1 42 11 62 22 ext +33    Amandine.MAULARD@gustaveroussy.fr   
Contact: Anne BISSERY, MD    1 42 16 24 32 ext +33    anne.bissery@aphp.fr   
Principal Investigator: Amandine MAULARD, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ecole d'econmie de Paris (PSE)-Hospinnomics
Université Montpellier
Université de Rennes 1 CREM CNRS UMR 6211
Investigators
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Principal Investigator: Geoffroy CANLORBE, MD Assistance Publique - Hôpitaux de Paris
Study Director: Lise ROCHAIX, MD PHD Hospinnomics
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03580421    
Other Study ID Numbers: P150966
2017-A02835-48 ( Registry Identifier: ID RCB )
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Endometrial Cancer
Health-economics analysis
Ambulatory surgery
QALY
discrete choice experiment
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases