Status:
COMPLETED
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
Lead Sponsor:
University Hospital, Linkoeping
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 l...
Detailed Description
If detailed description is requested, please contact sponsor.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01526655
Start Date
January 25 2012
End Date
July 27 2016
Last Update
April 18 2024
Active Locations (2)
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1
Department of Obstetrics and Gynecology, Ryhov Central Hospital
Jönköping, Jönköping County, Sweden, 551 85
2
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, Sweden, 58185