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

• Conditions: Oncology
• Interventions: Procedure: Enhanced recovery after surgery program

• Registration Number: NCT03950011
• Lead Sponsor: Institut Paoli-Calmettes

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).

Detailed 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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-09-20
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-13
• Last Update Submitted: 2019-05-13
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ERP	Enhanced recovery after surgery program	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.

Primary Outcome Measures

Name	Time	Method
Data collection	4 years	Restrospective and prospective data collection

Secondary Outcome Measures

Name	Time	Method
Evaluation of the quality of surgical management	4 days	characteristics of the surgery according to the type of diagnosis
Post-operative complications	4 days	post-operative complications in hospitalization and post-operative complications after leaving hospital

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France