NCT03950011

Brief Summary

Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

September 20, 2018

Last Update Submit

May 13, 2019

Conditions

Oncology

Keywords

Enhanced Recovery After Surgery Program (ERP)

Outcome Measures

Primary Outcomes (1)

  • Data collection

    Restrospective and prospective data collection

    4 years

Secondary Outcomes (2)

  • Evaluation of the quality of surgical management

    4 days

  • Post-operative complications

    4 days

Study Arms (1)

ERP

Any patient requiring oncologic surgery, including hysterectomy or curettage, posterior pelvectomy, conventional laparoscopic or assisted robotic surgery, or laparotomy for cervical or cervical cancer or ovarian cancer, body or cervix uterus and ovaries as well as benign pathologies or borderline malignancy.

Procedure: Enhanced recovery after surgery program

Interventions

Enhanced recovery after surgery programPROCEDURE

Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).

ERP

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsuterine or cervical cancer or ovarian cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.

You may qualify if:

  • Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.

You may not qualify if:

  • Non applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

Related Publications (1)

  • Lambaudie E, de Nonneville A, Brun C, Laplane C, N'Guyen Duong L, Boher JM, Jauffret C, Blache G, Knight S, Cini E, Houvenaeghel G, Blache JL. Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center. BMC Surg. 2017 Dec 28;17(1):136. doi: 10.1186/s12893-017-0332-9.

    PMID: 29282059RESULT

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Dominique Genre

CONTACT

+33491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

May 14, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

February 28, 2020

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations

FR(1)