An interventional study of 3-D laparoscopy and 2-D laparoscopy in Fibroma, Bleeding, sponsored by Zealand University Hospital. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-03.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Women not suitable for laparoscopic hysterectomy including:
traditional 2-D laparoscopy
Device: 2-D laparoscopy
experimental 3-D laparoscopy
Device: 3-D laparoscopy
3-D laparoscopy
2-D laparoscopy
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
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
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital