- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610985
2-D and 3-D Laparoscopic Hysterectomy
3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elise Hoffmann, MD
- Phone Number: +45 20252017
- Email: elisehoffmann78@gmail.com
Study Locations
-
-
Zealand
-
Roskilde, Zealand, Denmark, 4000
- Recruiting
- Sjaellands Univercety Hospital
-
Contact:
- Elise Hoffmann, MD
- Phone Number: 20252017
- Email: elisehoffmann78@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2-Dimensional laparoscopic hysterectomy
traditional 2-D laparoscopy
|
2-D laparoscopy
|
Experimental: 3-Dimensional laparoscopic hysterectomy
experimental 3-D laparoscopy
|
3-D laparoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on SF 36 psychical health survey 6 weeks after surgery
Time Frame: 6 weeks
|
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
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major complications during the operation, postoperative complications
Time Frame: 6 weeks
|
6 weeks
|
Minor complications during the operation, postoperative complications
Time Frame: 6 weeks
|
6 weeks
|
Score on SF 36 mental health survey 6 weeks after surgery
Time Frame: 6 weeks
|
6 weeks
|
Length of hospital stay
Time Frame: 6 weeks
|
6 weeks
|
Operative time
Time Frame: 4 hours
|
4 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2D/3D hysterectomy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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