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

Completed

• Conditions: UTERINE CERVICAL NEOPLASMS; ENDOMETRIAL NEOPLASMS
• Interventions: Procedure: Laparoscopy in Gynecologic Oncologic Indications; Procedure: Conventional surgery (abdominal radical surgery)

• Registration Number: NCT02865889
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2013-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 343

Inclusion Criteria

• Age>18 years
• Endometrial or cervical cancer

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uterine oncologic Indications for surgery	Laparoscopy in Gynecologic Oncologic Indications	-
Uterine oncologic Indications for surgery	Conventional surgery (abdominal radical surgery)	-

Primary Outcome Measures

Name	Time	Method
Cost comparison between Conventional vs Robotic-Assisted Laparoscopy	2 years	The following costs were included:Equipment costs,Instrument costs,Operating room costs,Hospital stay
Comparison of the effectiveness of procedures (Conventional vs Robotic-Assisted Laparoscopy)	2 years	Comparison of the effectiveness of procedures will take into account conversion rate, complications rate, metastatic and pelvic relapse

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, Bouches-du Rhône, France