2-D and 3-D Laparoscopic Hysterectomy

Z

Zealand University Hospital

Status

Unknown

Conditions

Fibroma, Bleeding

Treatments

Device: 3-D laparoscopy
Device: 2-D laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02610985
2D/3D hysterectomy

Details and patient eligibility

About

Background: No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse. Objective: To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time. Design: Investigator-initiated, blinded, randomised controlled trial. Intervention description: Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D. Trial size Roskilde/Herlev Hospital, Denmark: 200 patients in each arm of the study.

Enrollment

400 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.

Exclusion criteria

Women not suitable for laparoscopic hysterectomy including:

  • Ultrasound appraisal of uterus weight > 1000 gram
  • Need for prolapse surgery and therefore indication for vaginal hysterectomy.
  • Inability to give informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

400 participants in 2 patient groups

2-Dimensional laparoscopic hysterectomy
Active Comparator group
Description:
traditional 2-D laparoscopy
Treatment:
Device: 2-D laparoscopy
3-Dimensional laparoscopic hysterectomy
Experimental group
Description:
experimental 3-D laparoscopy
Treatment:
Device: 3-D laparoscopy

Trial contacts and locations

1

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Central trial contact

Elise Hoffmann, MD

Data sourced from clinicaltrials.gov

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