Minimally Invasive Benign Hysterectomy

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Menorrhagia; Metrorrhagia; Uterine Fibroids; Cervical Dysplasia	Device: Robotic hysterectomy; Procedure: Vaginal or laparoscopic hysterectomy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
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
Study Start Date :	January 2010
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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:

1. Social cost [ Time Frame: 4 months ]
   The length of postoperative sick leave and reasons for extending sick leave and cost thereof.

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Celine Lönnerfors, Medical Doctor, Region Skane
ClinicalTrials.gov Identifier:	NCT01865929 History of Changes
Other Study ID Numbers:	LundKK
First Posted:	May 31, 2013
Last Update Posted:	May 31, 2013
Last Verified:	May 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