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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT02865889

Collaborator

(none)

343

Enrollment

Location

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
UTERINE CERVICAL NEOPLASMS ENDOMETRIAL NEOPLASMS	Procedure: Laparoscopy in Gynecologic Oncologic Indications Procedure: Conventional surgery (abdominal radical surgery)

Study Design

Study Type:

Observational

Actual Enrollment :

343 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Uterine oncologic Indications for surgery	Procedure: Laparoscopy in Gynecologic Oncologic Indications Procedure: Conventional surgery (abdominal radical surgery)

Arm

Intervention/Treatment

Uterine oncologic Indications for surgery

Procedure: Laparoscopy in Gynecologic Oncologic Indications

Procedure: Conventional surgery (abdominal radical surgery)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age>18 years
Endometrial or cervical cancer

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli-Calmettes	Marseille	Bouches-du Rhône	France	13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator: Eric Lambaudie, MD,PhD, Institut Paoli-Calmettes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT02865889

Other Study ID Numbers:

STIC COELCO

First Posted:

Aug 15, 2016

Last Update Posted:

Aug 15, 2016

Last Verified:

Aug 1, 2016

Keywords provided by Institut Paoli-Calmettes

laparoscopic surgery

Uterine Neoplasms

Additional relevant MeSH terms:

Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Study Results

No Results Posted as of Aug 15, 2016