Minimally Invasive Benign Hysterectomy

Region Skane

Status: Completed

Conditions: Metrorrhagia; Uterine Fibroids; Cervical Dysplasia; Menorrhagia

Treatments: Device: Robotic hysterectomy; Procedure: Vaginal or laparoscopic hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01865929

LundKK

Details and patient eligibility

About

A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Full 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.

Enrollment: 124 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Robotic hysterectomy

Active Comparator group

Description:

Minimally invasive hysterectomy by robotic surgery

Treatment:

Procedure: Vaginal or laparoscopic hysterectomy

Vaginal or laparoscopic hysterectomy

Active Comparator group

Description:

Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Treatment:

Device: Robotic hysterectomy