Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery

Oncology Clinical Trial

— BDD RAAC  

Official title:

Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950011
• Other study ID #: BDD RAAC-IPC 2016-011
• Secondary ID: 2174848
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: February 28, 2020

Study information

• Verified date: May 2019
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Description:

This database would also allow an objective evaluation of the quality of the surgical management and the follow-up.

One of the evaluation criteria will be measured by the quantity and quality of publications from this database, and also by the increase in the activity of the service concerned.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non applicable.

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Procedure:
• Enhanced recovery after surgery program
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).

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & 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 e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection	Restrospective and prospective data collection	4 years
Secondary	Evaluation of the quality of surgical management	characteristics of the surgery according to the type of diagnosis	4 days
Secondary	Post-operative complications	post-operative complications in hospitalization and post-operative complications after leaving hospital	4 days