Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
NCT ID: NCT01526655
Last Updated: 2024-04-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2012-01-25
2016-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Robotic Versus Abdominal Surgery for Endometrial Cancer
NCT01847703
Minimally Invasive Benign Hysterectomy
NCT01865929
Quality of Life After Robotic Surgery for Endometrial Cancer
NCT04281043
Study Comparing Conventional vs. Robotic-assisted Laparoscopic Hysterectomy
NCT00485355
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
NCT01466777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abdominal total hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
Abdominal total hysterectomy
Abdominal total hysterectomy through a low transverse abdominal wall incision
Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abdominal total hysterectomy
Abdominal total hysterectomy through a low transverse abdominal wall incision
Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Linkoeping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Preben Kjolhede, MD, professor
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Preben Kjölhede, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Evelyn Lundin, MD
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Ninnie Borendal Wodlin, MD, PhD
Role: STUDY_CHAIR
Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Lena Nilsson, MD, PhD
Role: STUDY_CHAIR
Department of Anesthesiology, University Hospital, 58185 Linköping, Sweden
Jan Ernerudh, MD, PhD
Role: STUDY_CHAIR
Department of Clinical Immunology, University Hospital, 58185 Linköping, Sweden
Per Carlsson, PhD
Role: STUDY_CHAIR
Centre for Medical Technology Assessment, University Hospital, 58185 Linköping, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynecology, Ryhov Central Hospital
Jönköping, Jönköping County, Sweden
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ROBOTHYST
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.