UTERINE CERVICAL NEOPLASMSNCT02865889
Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications
An observational study of UTERINE CERVICAL NEOPLASMS and ENDOMETRIAL NEOPLASMS, run by Institut Paoli-Calmettes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- UTERINE CERVICAL NEOPLASMS, ENDOMETRIAL NEOPLASMS
- What is being tested?
- Laparoscopy in Gynecologic Oncologic Indications and Conventional surgery (abdominal radical surgery)
- Type of treatment
- Surgery or procedure
- How many people
- 343 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Endometrial and cervical cancer
Who may be able to join
- Age>18 years
- Endometrial or cervical cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Laparoscopy in Gynecologic Oncologic Indications, Conventional surgery (abdominal radical surgery)
- Keywords
- laparoscopic surgery, Uterine Neoplasms
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy in Gynecologic Oncologic IndicationsProcedure or surgery
Conventional surgery (abdominal radical surgery)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Uterine oncologic Indications for surgery | Not described Receives: Procedure: Laparoscopy in Gynecologic Oncologic Indications; Procedure: Conventional surgery (abdominal radical surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost comparison between Conventional vs Robotic-Assisted Laparoscopy
The following costs were included:Equipment costs,Instrument costs,Operating room costs,Hospital stay
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2008
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTERINE CERVICAL NEOPLASMSStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Lambaudie, MD,PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865889
- Sponsor's protocol ID
- STIC COELCO
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications
- ClinicalTrials.gov ID
- NCT02865889
- Acronym / sponsor ID
- STIC COELCO
- Conditions
- UTERINE CERVICAL NEOPLASMS, ENDOMETRIAL NEOPLASMS
- Keywords
- laparoscopic surgery, Uterine Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2013 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine oncologic Indications for surgery | – | Procedure: Laparoscopy in Gynecologic Oncologic Indications, Procedure: Conventional surgery (abdominal radical surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endometrial and cervical cancer
Key inclusion criteria (2 listed)
- Age>18 years
- Endometrial or cervical cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopy in Gynecologic Oncologic Indications | Procedure or surgery | Uterine oncologic Indications for surgery |
| Conventional surgery (abdominal radical surgery) | Procedure or surgery | Uterine oncologic Indications for surgery |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lambaudie, MD,PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of UTERINE CERVICAL NEOPLASMS and ENDOMETRIAL NEOPLASMS, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost comparison between Conventional vs Robotic-Assisted Laparoscopy (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016.