Status:

COMPLETED

Minimally Invasive Benign Hysterectomy

Lead Sponsor:

Region Skane

Conditions:

Menorrhagia

Metrorrhagia

Eligibility:

FEMALE

25+ years

Phase:

NA

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...

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 ha...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

124 Patients enrolled

Trial Details

Trial ID

NCT01865929

Start Date

January 1 2010

End Date

June 1 2013

Last Update

March 4 2024

Active Locations (1)

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1

Department of Obstetrics and Gynecology, Skane University Hospital

Lund, Sweden, 221 85