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

UTERINE CERVICAL NEOPLASMS Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865889
• Other study ID #: STIC COELCO
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 9, 2016
• Start date: September 2008

Study information

• Verified date: August 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 years

• Endometrial or cervical cancer

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ENDOMETRIAL NEOPLASMS
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Laparoscopy in Gynecologic Oncologic Indications

• Conventional surgery (abdominal radical surgery)

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille	Bouches-du Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost comparison between Conventional vs Robotic-Assisted Laparoscopy	The following costs were included:Equipment costs,Instrument costs,Operating room costs,Hospital stay	2 years	No
Primary	Comparison of the effectiveness of procedures (Conventional vs Robotic-Assisted Laparoscopy)	Comparison of the effectiveness of procedures will take into account conversion rate, complications rate, metastatic and pelvic relapse	2 years	No