Nomogram Control of Predictive Factors of Early Withdrawal After Gynecologic Oncology Surgery in the Enhanced Recovery After Surgery (ERAS) Protocol and Assessment of Practices (NomogramGyneco)

March 13, 2018 updated by: Institut Paoli-Calmettes
Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Validation of a predictive nomogram of short-term hospitalization (less than two days after surgery)
  • Analysis of the factors influencing the variations of average length of stay
  • Morbidity analysis of the ERAS program

Study Type

Observational

Enrollment (Anticipated)

370

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes

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

All patients who had surgery for gynecological cancer under the RAAC program.

Description

Inclusion Criteria:

  • All patients who had surgery for gynecological cancer under the ERAS program.

Exclusion Criteria:

  • None

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
Patients discharged before 2 days after surgery
patients discharged before 2 days of hospitalization following surgery
Other: Comparative analysis of the characteristics
  • Predictive nomogram of short-term hospitalization (less than two days after surgery)
  • Factors influencing the variations of average stay lenght
  • Morbidity of the ERAS program
Patients discharged after 2 days after surgery
patients discharging after 2 days of hospitalization following surgery
Other: Comparative analysis of the characteristics
  • Predictive nomogram of short-term hospitalization (less than two days after surgery)
  • Factors influencing the variations of average stay lenght
  • Morbidity of the ERAS program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.
Time Frame: 2 days
Validation of a predictive nomogram of short-term hospitalization (less than two days after surgery)
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive analysis of the cohort.
Time Frame: 1 day
Descriptive analysis of the cohort.
1 day
Analysis of the factors influencing the variations of average length of stay.
Time Frame: 1 day
Analysis of the factors influencing the variations of the average duration of stay in time.
1 day
Analysis of the variation of the average duration of stay in time.
Time Frame: 1 day
Analysis of the variation of the average duration of stay in time.
1 day
Morbidity analysis of the ERAS program.
Time Frame: 1 day
Morbidity analysis of the ERAS program
1 day
Description of the implementation of the ERAS program on the entire cohort.
Time Frame: 1 day
Description of the implementation of the ERAS program on the entire cohort.
1 day

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Eric LAMBAUDIE, 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 8, 2018

Primary Completion (Anticipated)

January 8, 2020

Study Completion (Anticipated)

February 8, 2020

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nomogramme Gyneco-IPC 2017-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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