Minimally Invasive Benign Hysterectomy

Not Applicable

Completed

• Conditions: Menorrhagia; Uterine Fibroids; Cervical Dysplasia; Metrorrhagia
• Interventions: Procedure: Vaginal or laparoscopic hysterectomy; Device: Robotic hysterectomy

• Registration Number: NCT01865929
• Lead Sponsor: Region Skane

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic hysterectomy	Vaginal or laparoscopic hysterectomy	Minimally invasive hysterectomy by robotic surgery
Vaginal or laparoscopic hysterectomy	Robotic hysterectomy	Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Primary Outcome Measures

Name	Time	Method
Cost of surgery	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient outcome	4 months	The number of patients in whom an intraoperative or postoperative complication occurs as well as the seriousness of the complication which occurs and what this entails for the patient in question. This includes conversions to open surgery as well as the need for reoperation and readmission.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Skane University Hospital; 🇸🇪 Lund, Sweden