Endometrial CancerRALHNCT01761721
Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
An observational study of Endometrial Cancer and Treatment by Robotic Assisted Laparoscopy Hysterectomy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer, Treatment by Robotic Assisted Laparoscopy Hysterectomy
- How many people
- 139 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Feb 2016
- How long will I take part?
- 4 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women suspected of endometrial cancer and treated with robot-assisted laparoscopic hysterectomy at Copenhagen University Hospital, Herlev.
Who may be able to join
- Women suspected of having Endometrial Cancer or having Atypical Complex hyperplasia
- Ability to understand and speak Danish
- Ability to cooperate
- Provision of written informed consent
Who cannot join
- Having a benign condition after histopathology postoperatively
- Bing assigned to radiation or chemotherapy postoperatively
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology, Copenhagen University Hospital, Herlev
Herlev, Herlev, 2730
About this study
The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia.
- Keywords
- Endometrial cancer (MeSH), Robotics (MeSH)
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RAHL | Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications Postoperative complications Postoperative complications Postoperative complications
Postoperative complications demanding treatment
Measured: 0-4 months follow-up
Secondary outcomes (2)
Postoperative pain
Postoperative pain measured by Brief Pain Inventory, baseline, 1 and 5 weeks and 4 months postoperatively
Measured: 0-4 months follow-up
Health Related Quality of Life
Health Related Quality of Life measured by QlQ-C30 and EN 24 (EORTC), EQ -5D, baseline, 1 and 5 weeks and 4 months postoperatively.
Measured: 0-4 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne F Herling, RN; MHSc, Principal investigator, Department of Anaesthesiology, Copenhagen University Hospital, Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761721
- Sponsor's protocol ID
- H-2-2012-FSP26
- Acronym
- RALH
- Status last verified
- Feb 2016
- First submitted
- 3 Jan 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Herling SF, Moller AM, Palle C, Thomsen T. Health-related quality of life after robotic-assisted laparoscopic hysterectomy for women with endometrial cancer--A prospective cohort study. Gynecol Oncol. 2016 Jan;140(1):107-13. doi: 10.1016/j.ygyno.2015.10.024. Epub 2015 Nov 2.
PubMed 26541978
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
- ClinicalTrials.gov ID
- NCT01761721
- Acronym / sponsor ID
- RALH / H-2-2012-FSP26
- Keywords
- Endometrial cancer (MeSH), Robotics (MeSH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Jan 2013 (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.
The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAHL | – | –Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women suspected of endometrial cancer and treated with robot-assisted laparoscopic hysterectomy at Copenhagen University Hospital, Herlev.
Key inclusion criteria (4 listed)
- Women suspected of having Endometrial Cancer or having Atypical Complex hyperplasia
- Ability to understand and speak Danish
- Ability to cooperate
- Provision of written informed consent
Key exclusion criteria (2 listed)
- Having a benign condition after histopathology postoperatively
- Bing assigned to radiation or chemotherapy postoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications Postoperative complications Postoperative complications Postoperative complications
Time frame: 0-4 months follow-up
Postoperative complications demanding treatment
2 secondary outcomes
Postoperative pain
Time frame: 0-4 months follow-up
Health Related Quality of Life
Time frame: 0-4 months follow-up
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 3 Feb 2016.
- Results publication: PubMed 26541978Herling SF, Moller AM, Palle C, Thomsen T. Health-related quality of life after robotic-assisted laparoscopic hysterectomy for women with endometrial cancer--A prospective cohort study. Gynecol Oncol. 2016 Jan;140(1):107-13. doi: 10.1016/j.ygyno.2015.10.024. Epub 2015 Nov 2.
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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.
Suzanne F Herling, RN; MHSc principal investigator
Department of Anaesthesiology, Copenhagen University Hospital, Herlev
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 and Treatment by Robotic Assisted Laparoscopy Hysterectomy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 4 inclusion and 2 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 3 Feb 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 Denmark. 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?
Postoperative complications Postoperative complications Postoperative complications Postoperative complications (time frame: 0-4 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761721, which also lists 1 linked publication.
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 3 Feb 2016.