Minimally Invasive Benign Hysterectomy
Conditions
Menorrhagia - Metrorrhagia - Uterine Fibroids - Cervical Dysplasia
Conditions: official terms
Cervical Intraepithelial Neoplasia - Leiomyoma - Menorrhagia - Metrorrhagia - Myofibroma - Uterine Cervical Dysplasia
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Robotic hysterectomy Type: Device
Name: Vaginal or laparoscopic hysterectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 25 Years
Gender: Female
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
Location
Department of Obstetrics and Gynecology, Skane University Hospital
Lund, Sweden
Status: Recruiting
Contact: Jan Persson, MD, PhD - jan.persson@med.lu.se
Start Date
January 2010
Completion Date
December 2015
Sponsors
Region Skane
Source
Region Skane
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page