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
Recruitment status was Recruiting
Sponsor:
Region Skane
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
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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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01865929
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
| 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:
|
Uterine Cervical Dysplasia Leiomyoma Myofibroma Menorrhagia 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 Menstruation Disturbances Pathologic Processes Precancerous Conditions Uterine Cervical Diseases Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Hemorrhage |
ClinicalTrials.gov processed this record on September 28, 2016