NCT01865929

Minimally Invasive Benign Hysterectomy

Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menorrhagia
• Metrorrhagia
• Uterine Fibroids
• Cervical Dysplasia

Interventions

Type	Name	Description
DEVICE	Robotic hysterectomy	Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy
PROCEDURE	Vaginal or laparoscopic hysterectomy	Benign hysterectomy performed by traditional minimal invasive procedures.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-05-31
• Last updated: 2024-03-04

Locations

1 site across 1 country: Sweden