Minimally Invasive Benign Hysterectomy

Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.

Study Overview

• Status: Completed
• Conditions: Metrorrhagia; Uterine Fibroids; Menorrhagia; Cervical Dysplasia
• Intervention / Treatment: Procedure: Vaginal or laparoscopic hysterectomy; Device: Robotic hysterectomy

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Persson, MD, PhD; Phone Number: +4646171000; Email: jan.persson@med.lu.se
• Study Contact Backup: Name: Celine Lönnerfors, MD; Phone Number: +4646171000; Email: celine.lonnerfors@med.lu.se

Study Locations

• Sweden
  • Lund, Sweden, 221 85
    • Department of Obstetrics and Gynecology, Skane University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: da Vinci Surgical system, Intuitive Surgical Inc, CA, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social cost	The length of postoperative sick leave and reasons for extending sick leave and cost thereof.	4 months

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Study Director: Jan Persson, MD, PhD, Department of Obstetrics and Gynecology, Skane University Hospital, Lund

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 8, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimated): May 31, 2013

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Hemorrhage; Precancerous Conditions; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Metrorrhagia; Leiomyoma; Uterine Cervical Dysplasia; Menorrhagia
• Other Study ID Numbers: LundKK