Endometrial CancerNCT01526655
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
A study testing Abdominal total hysterectomy and Robot assisted laparoscopic hysterectomy in people with Endometrial Cancer, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial summary
The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Abdominal total hysterectomy and Robot assisted laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- 25 Jan 2012to 27 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Over 18 years of age.
- Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and peritoneal lavage because of endometrial carcinoma, International federation of gynecology and obstetrics (FIGO) stage 1, grade 1 and 2, with diploid DNA profile (i.e. low risk profile).
- WHO (World Health Organisation) performance status ≤ 2.
- Proficiency in Swedish
- Accept to participate in the study and has signed written informed consent document.
- The operation should be considered possible to be perform laparoscopically and by laparotomy through a low transverse abdominal wall incision.
Who cannot join
- The operation is anticipated to comprise more than the hysterectomy + BSAE.
- A midline incision is planned for the laparotomy.
- Contraindications towards spinal anesthesia with intrathecally applied morphine.
- Physically disabled women who cannot be expected to be mobilized in accordance to the fast track program in a way similar to what is expected from not-physically disabled women.
- Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial.
- Severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Obstetrics and Gynecology, Ryhov Central Hospital
Jönköping, Jönköping County, 551 85
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, 58185
About this study
Official title: A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.
Read the detailed description
If detailed description is requested, please contact sponsor.
- Conditions
- Endometrial Cancer
- Being tested
- Abdominal total hysterectomy, Robot assisted laparoscopic hysterectomy
- Keywords
- Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal total hysterectomyProcedure or surgery
Abdominal total hysterectomy through a low transverse abdominal wall incision
Robot assisted laparoscopic hysterectomyProcedure or surgery
Robot assisted laparoscopic total hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Abdominal total hysterectomy | Active comparator | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision Receives: Procedure: Abdominal total hysterectomy |
| Robot assisted laparoscopic hysterectomy | Active comparator | Robot assisted laparoscopic total hysterectomy Receives: Procedure: Robot assisted laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQoL)
Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.
Measured: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Secondary outcomes (7)
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Measured: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Measured: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Measured: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Measured: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Cortisol)
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
Measured: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Health Economics (With 300 Robotic Procedures Annually)
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
Measured: From the day of surgery until six weeks after surgery.
Health Economics (With 500 Robotic Procedures Annually)
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
Measured: From the day of surgery until six weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study start25 Jan 2012
- Primary completion27 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preben Kjolhede, MD, professor, University Hospital, Linkoeping
- Investigators
- Preben Kjölhede, MD, PhD, Study chair, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, SwedenEvelyn Lundin, MD, Study director, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, SwedenNinnie Borendal Wodlin, MD, PhD, Study chair, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, SwedenLena Nilsson, MD, PhD, Study chair, Department of Anesthesiology, University Hospital, 58185 Linköping, SwedenJan Ernerudh, MD, PhD, Study chair, Department of Clinical Immunology, University Hospital, 58185 Linköping, SwedenPer Carlsson, PhD, Study chair, Centre for Medical Technology Assessment, University Hospital, 58185 Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526655
- Sponsor's protocol ID
- ROBOTHYST
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2012
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
- ClinicalTrials.gov ID
- NCT01526655
- Acronym / sponsor ID
- ROBOTHYST
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 25 Jan 2012 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.
Detailed description
If detailed description is requested, please contact sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal total hysterectomy | Active comparator | Procedure: Abdominal total hysterectomyStandard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision |
| Robot assisted laparoscopic hysterectomy | Active comparator | Procedure: Robot assisted laparoscopic hysterectomyRobot assisted laparoscopic total hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years of age.
- Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and peritoneal lavage because of endometrial carcinoma, International federation of gynecology and obstetrics (FIGO) stage 1, grade 1 and 2, with diploid DNA profile (i.e. low risk profile).
- WHO (World Health Organisation) performance status ≤ 2.
- Proficiency in Swedish
- Accept to participate in the study and has signed written informed consent document.
Key exclusion criteria (6 listed)
- The operation is anticipated to comprise more than the hysterectomy + BSAE.
- A midline incision is planned for the laparotomy.
- Contraindications towards spinal anesthesia with intrathecally applied morphine.
- Physically disabled women who cannot be expected to be mobilized in accordance to the fast track program in a way similar to what is expected from not-physically disabled women.
- Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial.
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 |
|---|---|---|
| Abdominal total hysterectomyAbdominal total hysterectomy through a low transverse abdominal wall incision | Procedure or surgery | Abdominal total hysterectomy |
| Robot assisted laparoscopic hysterectomyRobot assisted laparoscopic total hysterectomy | Procedure or surgery | Robot assisted laparoscopic hysterectomy |
Primary outcome
Health Related Quality of Life (HRQoL)
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.
7 secondary outcomes
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Cortisol)
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Health Economics (With 300 Robotic Procedures Annually)
Time frame: From the day of surgery until six weeks after surgery.
Health Economics (With 500 Robotic Procedures Annually)
Time frame: From the day of surgery until six weeks after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Preben Kjölhede, MD, PhD study chair
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Evelyn Lundin, MD study director
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Ninnie Borendal Wodlin, MD, PhD study chair
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal total hysterectomy and Robot assisted laparoscopic hysterectomy in people with Endometrial Cancer, run by University Hospital, Linkoeping at 2 sites in Sweden.
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 6 inclusion and 6 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Health Related Quality of Life (HRQoL) (time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42). 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 18 Apr 2024.