Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis (CARPEMAN)

July 8, 2019 updated by: Centre Francois Baclesse
This is a Multicenter prospective diagnostic study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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
      • Amiens, France
        • CHU
      • Caen, France
        • CHU
      • Caen, France
        • Centre Françis Baclesse
      • Nantes, France
        • Institut de Cancérologie de l'Ouest
      • Rouen, France
        • Centre Henri Becquerel

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

Description

Inclusion Criteria:

  • Over 18 years of age Patient
  • Woman presenting a peritoneal carcinosis presumed ovarian origin
  • Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
  • WHO 0 - 2
  • Membership in a social security system
  • Patient having given her written consent

Exclusion Criteria:

  • Male
  • Contraindication in the coelioscopy
  • Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
  • Patient deprived of freedom, under guardianship or guardianship

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manual exploration by GelPort
manual exploration in supplement of coelioscopy before laparotomy
Procedure: GelPort
Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability
Procedure: laparotomy
laparotomy will be performed if indication confirmed by manual exploration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the number of patients with or without laparotomy after evaluation of the resectability by coelioscopy and coelioscopy more manual exploration
Time Frame: 1 month after inclusion
1 month after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with complications (eventrations, infections, pains) after manual exploration
Time Frame: 1 month after inclusion
1 month after inclusion
Number of patients with parietal metastases
Time Frame: 1 month after inclusion
1 month after inclusion

Collaborators and Investigators

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

Sponsor

Centre Francois Baclesse

Collaborators

Groupement Interrégional de Recherche Clinique et d'Innovation

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)

September 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 7, 2015

First Posted (Estimate)

July 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00615-44

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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