Clinical Trial: 2-D and 3-D Laparoscopic Hysterectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial

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 Summary:
Sponsor: University Hospital Roskilde

Current Primary Outcome:

  • Score on SF 36 psychical health survey 6 weeks after surgery [ Time Frame: 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. [ Time Frame: 3 days ]


Original Primary Outcome:

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


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Complications during the operation, postoperative complications [ Time Frame: 6 weeks ]
  • time to return to work [ Time Frame: 6 weeks ]
  • Length of hospital stay [ Time Frame: 6 weeks ]
  • Operative time [ Time Frame: 4 hours ]


Information By: University Hospital Roskilde

Dates:
Date Received: November 16, 2015
Date Started: September 2016
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016