Status:
COMPLETED
Minimally Invasive Benign Hysterectomy
Lead Sponsor:
Region Skane
Conditions:
Menorrhagia
Metrorrhagia
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost...
Detailed Description
Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery ha...
Eligibility Criteria
Inclusion
- indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- size of uterus and vagina allows for retrieval by the vaginal route
- maximum uterine size equivalent to 16 weeks of pregnancy
- informed consent
Exclusion
- malignant disease
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopic surgery
- women with pacemaker or other implants where electrosurgery is to be avoided
- immunoincompetent women
- simultaneous need for prolapse surgery
- women with known defects of the hemostasis
- allergies towards metronidazole and doxycycline
- inability to understand patient information
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01865929
Start Date
January 1 2010
End Date
June 1 2013
Last Update
March 4 2024
Active Locations (1)
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1
Department of Obstetrics and Gynecology, Skane University Hospital
Lund, Sweden, 221 85