Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
25 Years
N/A
Female
Menorrhagia, Metrorrhagia, Uterine Fibroids, Cervical Dysplasia
Trial Information
Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cost of surgery
Outcome Description:
The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost.
Outcome Time Frame:
4 months
Safety Issue:
No
Principal Investigator
Jan Persson, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Department of Obstetrics and Gynecology, Skane University Hospital, Lund
Authority:
Sweden: Institutional Review Board
Study ID:
LundKK
NCT ID:
NCT01865929
Start Date:
January 2010
Completion Date:
December 2015
Related Keywords:
- Menorrhagia
- Metrorrhagia
- Uterine Fibroids
- Cervical Dysplasia
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
- Leiomyoma
- Menorrhagia
- Metrorrhagia
- Myofibroma
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