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Completed

NCT Number: NCT02493972

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

This is a Multicenter prospective diagnostic study.

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Key information

Conditions

Ovarian Cancer With Peritoneal Carcinosis Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GelPort

Procedure

Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability

Laparotomy

Procedure

laparotomy will be performed if indication confirmed by manual exploration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Groupement Interrégional de Recherche Clinique et d'Innovation

Registry information

Acronym: CARPEMAN

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2015
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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