Minimally Invasive Benign Hysterectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2013 by Celine Lönnerfors, Region Skane.
Recruitment status was: Recruiting

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

History of Changes

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: None (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:

MedlinePlus related topics: Hysterectomy

Genetic and Rare Diseases Information Center resources: Cervical Intraepithelial Neoplasia

U.S. FDA Resources

Further study details as provided by Celine Lönnerfors, Region Skane:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Other Outcome Measures:

Social cost [ Time Frame: 4 months ]
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)
Sexes 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


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

Additional relevant MeSH terms:


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 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 19, 2017

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