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OpenTrials
Completed

NCT Number: NCT02885779

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

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.

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Key information

Conditions

Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, 13273, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Immediate post operative pains

    Time frame: Up to 1 month

    consumption of analgesic for pains in immediate operating comment

  2. Court term post operative pains

    Time frame: Up to 2 month

    consumption of analgesic for pains

  3. Medium term post operative pains

    Time frame: Up to 3 month

    consumption of analgesic for pains

Secondary outcomes

  1. Complications per operating

    Time frame: During surgery

    Blood loss

  2. Complications per operating

    Time frame: During surgery

    Addition of trocar

  3. Complications post operating

    Time frame: Up to 1 month

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: ANTATROC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 1, 2016
Registry last updated
Sep 1, 2016

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.