Brief Title
Minimally Invasive Benign Hysterectomy
Official Title
Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
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 analyses.
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 have facilitated a higher proportion of minimally invasive surgery first
and foremost within gynecologic oncology.It is not clear whether or not this is true for less
advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.
Robot-assisted surgery is associated with additional cost due to investment and more
expensive surgical equipment. The study is performed to investigate whether or not performing
hysterectomy for benign conditions with robotic surgery will be advantageous in terms of
shorter operating time, less complications, less conversions to open surgery, and shorter
hospital stay in comparison to other minimally invasive procedures such as vaginal
hysterectomy and traditional laparoscopic hysterectomy.
Study Type
Interventional
Primary Outcome
Cost of surgery
Secondary Outcome
Patient outcome
Condition
Menorrhagia
Intervention
Robotic hysterectomy
Study Arms / Comparison Groups
Robotic hysterectomy
Description: Minimally invasive hysterectomy by robotic surgery
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
Device
Estimated Enrollment
200
Start Date
January 2010
Completion Date
December 2015
Primary Completion Date
September 2014
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
Female
Ages
25 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jan Persson, MD, PhD, +4646171000, [email protected]
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01865929
Organization ID
LundKK
Responsible Party
Principal Investigator
Study Sponsor
Region Skane
Study Sponsor
Jan Persson, MD, PhD, Study Director, Department of Obstetrics and Gynecology, Skane University Hospital, Lund
Verification Date
May 2013