Fibroma, Bleeding
Conditions
Keywords
Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy
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.
Interventions
DEVICE3-D laparoscopy
3-D laparoscopy
DEVICE2-D laparoscopy
2-D laparoscopy
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Score on SF 36 mental health survey 6 weeks after surgery | 6 weeks |
| Major complications during the operation, postoperative complications | 6 weeks |
| Operative time | 4 hours |
| Length of hospital stay | 6 weeks |
| Minor complications during the operation, postoperative complications | 6 weeks |
Countries
Denmark
Contacts
Primary ContactElise Hoffmann, MD
Outcome results
None listed