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

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ClinicalTrials.gov Identifier: NCT02493972
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Groupement Interrégional de Recherche Clinique et d'Innovation
Information provided by (Responsible Party):
Centre Francois Baclesse

Study Description
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Brief Summary:
This is a Multicenter prospective diagnostic study.

Condition or disease Intervention/treatment Phase
Ovarian Cancer With Peritoneal Carcinosis Procedure: GelPort Procedure: laparotomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : September 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of patients with complications (eventrations, infections, pains) after manual exploration [ Time Frame: 1 month after inclusion ]
  2. Number of patients with parietal metastases [ Time Frame: 1 month after inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493972


Locations
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France
CHU
Amiens, France
Centre Françis Baclesse
Caen, France
CHU
Caen, France
Institut de Cancérologie de l'Ouest
Nantes, France
Centre Henri Becquerel
Rouen, France
Sponsors and Collaborators
Centre Francois Baclesse
Groupement Interrégional de Recherche Clinique et d'Innovation
More Information
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT02493972     History of Changes
Other Study ID Numbers: 2015-A00615-44
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by Centre Francois Baclesse:
ovarian cancer
peritoneal carcinosis
manual exploration
surgery
GelPort
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders