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OpenTrials
Completed

NCT Number: NCT02865889

Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only.

Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.

This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage).

Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs.

This program will focus on uterine cancer (both cervix and corpus).

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age>18 years
  • Endometrial or cervical cancer

Exclusion criteria

-

Treatment and study plan

Laparoscopy in Gynecologic Oncologic Indications

Procedure

Conventional surgery (abdominal radical surgery)

Procedure

Primary outcomes

  1. Cost comparison between Conventional vs Robotic-Assisted Laparoscopy

    Time frame: 2 years

    The following costs were included:Equipment costs,Instrument costs,Operating room costs,Hospital stay

  2. Comparison of the effectiveness of procedures (Conventional vs Robotic-Assisted Laparoscopy)

    Time frame: 2 years

    Comparison of the effectiveness of procedures will take into account conversion rate, complications rate, metastatic and pelvic relapse

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
First posted
Aug 15, 2016
Registry last updated
Aug 15, 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.

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