Assessment of Tele-expertise for Frozen Section Diagnosis (Télé-extempo)

December 8, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis

The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

253

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
      • Clamart, France, 92140
        • Service d'Anatomie pathologique. Hôpital Antoine Béclère
      • Le Kremlin Bicêtre, France, 94275
        • Service d'anatomie pathologique. Hôpital Bicêtre
      • Montfermeil, France, 93370
        • Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil
      • Montfermeil, France, 93370
        • Service d'ORL. Hôpital du Raincy-Montfermeil
      • Paris, France, 75012
        • Service d'anatomie pathologique. Hôpital Saint Antoine
      • Paris, France, 75012
        • Service de chirurgie viscérale. Hôpital des Diaconnesses

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who need a frozen section diagnosis

Description

Inclusion Criteria:

  • All patients

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
During tele-expertise
Remote site interpretation of frozen section
Device: During Tele-expertise
Before tele-expertise
Usual (on site) frozen section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon
Time Frame: 30 minutes after the sample extraction
30 minutes after the sample extraction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay between extraction of the sample and the diagnosis given to the surgeon
Time Frame: 24h after procedure
24h after procedure
Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis
Time Frame: Once a month
Once a month
Overall cost of a frozen section diagnosis
Time Frame: 6 months after the first patient enrollment
Sum of the durations of the professionals immobilization for performing a diagnosis x wages + costs of the telemedicine solution development and implementation.
6 months after the first patient enrollment

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence Regionale de Sante d'Ile de France

Investigators

  • Principal Investigator: Isabelle Durand-Zaleski, MD, PhD, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Catherine Guettier, MD, PhD, Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris

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

Helpful Links

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

January 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 15, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • TLM-Pathology Frozen Section

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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