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Minimally Invasive Benign Hysterectomy

Primary Purpose

Menorrhagia, Metrorrhagia, Uterine Fibroids

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Robotic hysterectomy
Vaginal or laparoscopic hysterectomy
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, Skane University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Robotic hysterectomy

Vaginal or laparoscopic hysterectomy

Arm Description

Minimally invasive hysterectomy by robotic surgery

Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Outcomes

Primary Outcome Measures

Cost of surgery
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
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.

Full Information

First Posted
April 8, 2013
Last Updated
May 30, 2013
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01865929
Brief Title
Minimally Invasive Benign Hysterectomy
Official Title
Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Metrorrhagia, Uterine Fibroids, Cervical Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic hysterectomy
Arm Type
Active Comparator
Arm Description
Minimally invasive hysterectomy by robotic surgery
Arm Title
Vaginal or laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.
Intervention Type
Device
Intervention Name(s)
Robotic hysterectomy
Other Intervention Name(s)
da Vinci Surgical system, Intuitive Surgical Inc, CA, USA
Intervention Description
Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
Vaginal or laparoscopic hysterectomy
Intervention Description
Benign hysterectomy performed by traditional minimal invasive procedures.
Primary Outcome Measure Information:
Title
Cost of surgery
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Patient outcome
Description
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.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Social cost
Description
The length of postoperative sick leave and reasons for extending sick leave and cost thereof.
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Persson, MD, PhD
Phone
+4646171000
Email
jan.persson@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Celine Lönnerfors, MD
Phone
+4646171000
Email
celine.lonnerfors@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Persson, MD, PhD
Organizational Affiliation
Department of Obstetrics and Gynecology, Skane University Hospital, Lund
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Persson, MD, PhD
Email
jan.persson@med.lu.se
First Name & Middle Initial & Last Name & Degree
Jan Persson, MD, PhD
First Name & Middle Initial & Last Name & Degree
Celine Lönnerfors, MD

12. IPD Sharing Statement

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Minimally Invasive Benign Hysterectomy

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