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Completed

NCT Number: NCT01865929

Minimally Invasive Benign Hysterectomy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic hysterectomy

Device

Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy

Other names: da Vinci Surgical system, Intuitive Surgical Inc, CA, USA

Vaginal or laparoscopic hysterectomy

Procedure

Benign hysterectomy performed by traditional minimal invasive procedures.

Primary outcomes

  1. Cost of surgery

    Time frame: 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 outcomes

  1. Patient outcome

    Time frame: 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.

Other outcomes

  1. Social cost

    Time frame: 4 months

    The length of postoperative sick leave and reasons for extending sick leave and cost thereof.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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