Brief Title
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
Official Title
A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
Brief 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.
Detailed Description
If detailed description is requested, please contact sponsor.
Study Type
Interventional
Primary Outcome
Quality of life
Secondary Outcome
Changes in biomarkers for tissue damage
Condition
Endometrial Cancer
Intervention
Abdominal total hysterectomy
Study Arms / Comparison Groups
Abdominal total hysterectomy
Description: Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
50
Start Date
January 25, 2012
Completion Date
July 27, 2016
Primary Completion Date
July 27, 2016
Eligibility Criteria
Inclusion Criteria:
- 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 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:
- 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Preben Kjölhede, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01526655
Organization ID
ROBOTHYST
Responsible Party
Principal Investigator
Study Sponsor
University Hospital, Linkoeping
Study Sponsor
Preben Kjölhede, MD, PhD, Study Chair, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Verification Date
December 2018