Minimally Invasive Benign Hysterectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Celine Lönnerfors, Region Skane
ClinicalTrials.gov Identifier:
NCT01865929
First received: April 8, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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
Menorrhagia
Metrorrhagia
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865929

Contacts
Contact: Jan Persson, MD, PhD +4646171000 jan.persson@med.lu.se
Contact: Celine Lönnerfors, MD +4646171000 celine.lonnerfors@med.lu.se

Locations
Sweden
Department of Obstetrics and Gynecology, Skane University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Jan Persson, MD, PhD       jan.persson@med.lu.se   
Principal Investigator: Jan Persson, MD, PhD         
Sub-Investigator: Celine Lönnerfors, MD         
Sponsors and Collaborators
Region Skane
Investigators
Study Director: Jan Persson, MD, PhD Department of Obstetrics and Gynecology, Skane University Hospital, Lund
  More Information

No publications provided

Responsible Party: Celine Lönnerfors, Medical Doctor, Region Skane
ClinicalTrials.gov 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:
Menstruation Disturbances
Leiomyoma
Myofibroma
Menorrhagia
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Metrorrhagia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Precancerous Conditions
Uterine Cervical Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Hemorrhage

ClinicalTrials.gov processed this record on September 22, 2014