Minimally Invasive Benign Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by Region Skane.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Celine Lönnerfors, Region Skane Identifier:
First received: April 8, 2013
Last updated: May 30, 2013
Last verified: May 2013
A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Condition Intervention
Uterine Fibroids
Cervical Dysplasia
Device: Robotic hysterectomy
Procedure: Vaginal or laparoscopic hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

Resource links provided by NLM:

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Cost of surgery [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • Patient outcome [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Social cost [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The length of postoperative sick leave and reasons for extending sick leave and cost thereof.

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Robotic hysterectomy
Minimally invasive hysterectomy by robotic surgery
Procedure: Vaginal or laparoscopic hysterectomy
Benign hysterectomy performed by traditional minimal invasive procedures.
Active Comparator: Vaginal or laparoscopic hysterectomy
Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.
Device: Robotic hysterectomy
Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy
Other Name: da Vinci Surgical system, Intuitive Surgical Inc, CA, USA

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.


Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01865929

Contact: Jan Persson, MD, PhD +4646171000
Contact: Celine Lönnerfors, MD +4646171000

Department of Obstetrics and Gynecology, Skane University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Jan Persson, MD, PhD   
Principal Investigator: Jan Persson, MD, PhD         
Sub-Investigator: Celine Lönnerfors, MD         
Sponsors and Collaborators
Region Skane
Study Director: Jan Persson, MD, PhD Department of Obstetrics and Gynecology, Skane University Hospital, Lund
  More Information

Responsible Party: Celine Lönnerfors, Medical Doctor, Region Skane Identifier: NCT01865929     History of Changes
Other Study ID Numbers: LundKK 
Study First Received: April 8, 2013
Last Updated: May 30, 2013
Health Authority: Sweden: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Connective Tissue Diseases
Genital Diseases, Female
Menstruation Disturbances
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Neoplasms, Muscle Tissue
Pathologic Processes
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Uterine Hemorrhage processed this record on May 26, 2016