Minimally Invasive Benign Hysterectomy
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|ClinicalTrials.gov Identifier: NCT01865929|
Recruitment Status : Unknown
Verified May 2013 by Celine Lönnerfors, Region Skane.
Recruitment status was: Recruiting
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia Metrorrhagia Uterine Fibroids Cervical Dysplasia||Device: Robotic hysterectomy Procedure: Vaginal or laparoscopic hysterectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2015|
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
- 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.
- 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.
- Social cost [ Time Frame: 4 months ]The length of postoperative sick leave and reasons for extending sick leave and cost thereof.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865929
|Contact: Jan Persson, MD, PhDfirstname.lastname@example.org|
|Contact: Celine Lönnerfors, MDemail@example.com|
|Department of Obstetrics and Gynecology, Skane University Hospital||Recruiting|
|Lund, Sweden, 221 85|
|Contact: Jan Persson, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Jan Persson, MD, PhD|
|Sub-Investigator: Celine Lönnerfors, MD|
|Study Director:||Jan Persson, MD, PhD||Department of Obstetrics and Gynecology, Skane University Hospital, Lund|