Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery (BDD RAAC)

May 13, 2019 updated by: Institut Paoli-Calmettes
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes
        • Principal Investigator:
          • Eric Lambaudie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection
Time Frame: 4 years
Restrospective and prospective data collection
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the quality of surgical management
Time Frame: 4 days
characteristics of the surgery according to the type of diagnosis
4 days
Post-operative complications
Time Frame: 4 days
post-operative complications in hospitalization and post-operative complications after leaving hospital
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

February 28, 2020

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDD RAAC-IPC 2016-011
  • 2174848 (Other Identifier: CNIL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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