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

NCT02865889 | Completed

• 1 other identifier: STIC COELCO
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

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).

Conditions

UTERINE CERVICAL NEOPLASMS; ENDOMETRIAL NEOPLASMS

Keywords

laparoscopic surgery; Uterine Neoplasms

Outcome Measures

Primary Outcomes (2)

• Cost comparison between Conventional vs Robotic-Assisted Laparoscopy

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

  2 years

• 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

Study Arms (1)

Uterine oncologic Indications for surgery

Procedure: Laparoscopy in Gynecologic Oncologic Indications; Procedure: Conventional surgery (abdominal radical surgery)

Interventions

Laparoscopy in Gynecologic Oncologic Indications PROCEDURE

Uterine oncologic Indications for surgery

Conventional surgery (abdominal radical surgery) PROCEDURE

Uterine oncologic Indications for surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Endometrial and cervical cancer

You may qualify if:

• Age\>18 years
• Endometrial or cervical cancer

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Uterine Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Eric Lambaudie, MD,PhD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 15, 2016
• Study Start: September 1, 2008
• Primary Completion: March 1, 2013
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

FR (1)