2-D and 3-D Laparoscopic Hysterectomy

Not Applicable

• Conditions: Fibroma, Bleeding
• Interventions: Device: 2-D laparoscopy; Device: 3-D laparoscopy

• Registration Number: NCT02610985
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2016-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-01
• Last Update Posted: 2018-04-03
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Dimensional laparoscopic hysterectomy	2-D laparoscopy	traditional 2-D laparoscopy
3-Dimensional laparoscopic hysterectomy	3-D laparoscopy	experimental 3-D laparoscopy

Primary Outcome Measures

Name	Time	Method
Score on SF 36 psychical health survey 6 weeks after surgery	6 weeks
Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.	3 days

Secondary Outcome Measures

Name	Time	Method
Operative time	4 hours
Major complications during the operation, postoperative complications	6 weeks
Minor complications during the operation, postoperative complications	6 weeks
Score on SF 36 mental health survey 6 weeks after surgery	6 weeks
Length of hospital stay	6 weeks

Trial Locations

Locations (1)

Sjaellands Univercety Hospital; 🇩🇰 Roskilde, Zealand, Denmark