Endometrial CancerNCT05969405
Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy
An observational study of Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Objective：To compare the clinical outcomes of endometrial cancer patients who received surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and laparotomic methods Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Laparoscopic staging, Robotic staging and Laparotomic staging
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2023to 31 Dec 2024
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: endometrial cancer patients
Who may be able to join
- womwn who received endometrial cancer surgical from January 01, 2008 to November 30, 2022 were be reviewed.
Who cannot join
- Endometrial cancer patients did not undergo surgery.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
Objective：To compare the clinical outcomes of endometrial cancer patients who received surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and laparotomic methods
Read the detailed description
We will review the medical records of clinically uterine-confined endometrial cancer women who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare their outcomes.
- Conditions
- Endometrial Cancer
- Being tested
- Laparoscopic staging, Robotic staging, Laparotomic staging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic stagingProcedure or surgery
Laparoscopic staging
Robotic stagingProcedure or surgery
Robotic staging
Laparotomic stagingProcedure or surgery
Laparotomic staging
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Laparoscopic staging group Receives: Procedure: Laparoscopic staging | |
| Robotic | Robotic staing group Receives: Procedure: Robotic staging | |
| Laparotomic | Laparotomic group Receives: Procedure: Laparotomic staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 5 years
Secondary outcomes (5)
Progression free survival
Progression free survival
Measured: 5 years
length of hospital stay
length of hospital stay
Measured: 2 weeks
surgical time
surgical time
Measured: 1 day
Estimate blood loss
Estimate blood loss
Measured: 1 day
lymph node number
dissected lymph node number
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969405
- Sponsor's protocol ID
- 112002-E
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy
- ClinicalTrials.gov ID
- NCT05969405
- Acronym / sponsor ID
- 112002-E
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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.
Objective：To compare the clinical outcomes of endometrial cancer patients who received surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and laparotomic methods
Detailed description
We will review the medical records of clinically uterine-confined endometrial cancer women who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare their outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | – | Procedure: Laparoscopic stagingLaparoscopic staging group |
| Robotic | – | Procedure: Robotic stagingRobotic staing group |
| Laparotomic | – | Procedure: Laparotomic stagingLaparotomic group |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- endometrial cancer patients
Key inclusion criteria (1 listed)
- womwn who received endometrial cancer surgical from January 01, 2008 to November 30, 2022 were be reviewed.
Key exclusion criteria (1 listed)
- Endometrial cancer patients did not undergo surgery.
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 |
|---|---|---|
| Laparoscopic stagingLaparoscopic staging | Procedure or surgery | Laparoscopy |
| Robotic stagingRobotic staging | Procedure or surgery | Robotic |
| Laparotomic stagingLaparotomic staging | Procedure or surgery | Laparotomic |
Primary outcome
Overall survival
Time frame: 5 years
Overall survival
5 secondary outcomes
Progression free survival
Time frame: 5 years
length of hospital stay
Time frame: 2 weeks
surgical time
Time frame: 1 day
Estimate blood loss
Time frame: 1 day
lymph node number
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, Taiwan
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 Endometrial Cancer, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 1 Aug 2023.