Minimally Invasive Benign Hysterectomy

NCT01865929 | Completed

• 1 other identifier: LundKK
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Menorrhagia; Metrorrhagia; Uterine Fibroids; Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient outcome

  4 months

Other Outcomes (1)

• Social cost

  4 months

Study Arms (2)

Robotic hysterectomy

ACTIVE COMPARATOR

Minimally invasive hysterectomy by robotic surgery

Procedure: Vaginal or laparoscopic hysterectomy

Vaginal or laparoscopic hysterectomy

ACTIVE COMPARATOR

Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Device: Robotic hysterectomy

Interventions

Robotic hysterectomy DEVICE

Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy

Also known as: da Vinci Surgical system, Intuitive Surgical Inc, CA, USA

Vaginal or laparoscopic hysterectomy

Vaginal or laparoscopic hysterectomy PROCEDURE

Benign hysterectomy performed by traditional minimal invasive procedures.

Robotic hysterectomy

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Skane University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Menorrhagia; Metrorrhagia; Leiomyoma; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Precancerous Conditions; Uterine Cervical Diseases

Study Officials

• Jan Persson, MD, PhD

  Department of Obstetrics and Gynecology, Skane University Hospital, Lund

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

SE (1)