Minimally Invasive Benign Hysterectomy

NCT ID: NCT01865929

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Menorrhagia; Metrorrhagia; Uterine Fibroids; Cervical Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic hysterectomy

Minimally invasive hysterectomy by robotic surgery

Group Type: ACTIVE_COMPARATOR

Vaginal or laparoscopic hysterectomy

Intervention Type: PROCEDURE

Benign hysterectomy performed by traditional minimal invasive procedures.

Vaginal or laparoscopic hysterectomy

Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery.

Group Type: ACTIVE_COMPARATOR

Robotic hysterectomy

Intervention Type: DEVICE

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

Interventions

Robotic hysterectomy

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

Intervention Type: DEVICE

Vaginal or laparoscopic hysterectomy

Benign hysterectomy performed by traditional minimal invasive procedures.

Intervention Type: PROCEDURE

Other Intervention Names

da Vinci Surgical system, Intuitive Surgical Inc, CA, USA

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Persson, MD, PhD

Role: STUDY_DIRECTOR

Department of Obstetrics and Gynecology, Skane University Hospital, Lund

Locations

Department of Obstetrics and Gynecology, Skane University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

LundKK

Identifier Type: -

Identifier Source: org_study_id