2-D and 3-D Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibroma, Bleeding

Intervention / Treatment
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* Device: 3-D laparoscopy
* Device: 2-D laparoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2-Dimensional laparoscopic hysterectomy<br>traditional 2-D laparoscopy | Device: 2-D laparoscopy<br>* 2-D laparoscopy<br>|
| Experimental: 3-Dimensional laparoscopic hysterectomy<br>experimental 3-D laparoscopy | Device: 3-D laparoscopy<br>* 3-D laparoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Operative time |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Three-Dimensional, Hysterectomy, laparoscopic hysterectomy