Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study. (ANTATROC)

August 26, 2016 updated by: Institut Paoli-Calmettes

The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

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
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • 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

Operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Description

Inclusion Criteria :

  • Age > 18 ans
  • OMS = 2
  • Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

Exclusion Criteria:

  • Contraindication to coelioscopy intervention

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patient having an operating indication of adnexa surgery
Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate post operative pains
Time Frame: Up to 1 month
consumption of analgesic for pains in immediate operating comment
Up to 1 month
Court term post operative pains
Time Frame: Up to 2 month
consumption of analgesic for pains
Up to 2 month
Medium term post operative pains
Time Frame: Up to 3 month
consumption of analgesic for pains
Up to 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications per operating
Time Frame: During surgery
Blood loss
During surgery
Complications per operating
Time Frame: During surgery
Addition of trocar
During surgery
Complications post operating
Time Frame: Up to 1 month
Duration of hospitalization
Up to 1 month

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

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

May 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTATROC-IPC 2015-011

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe