Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
400 participants
INTERVENTIONAL
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
NCT02192606
3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy
NCT04070872
2D Versus 3D Radical Laparoscopic Hysterectomy for Endometrial Cancer: a Prospective Randomized Trial
NCT02320565
Vaginal vs. Laparoscopic Hysterectomy
NCT02059954
Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
NCT01581905
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
2-Dimensional laparoscopic hysterectomy
traditional 2-D laparoscopy
2-D laparoscopy
2-D laparoscopy
3-Dimensional laparoscopic hysterectomy
experimental 3-D laparoscopy
3-D laparoscopy
3-D laparoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3-D laparoscopy
3-D laparoscopy
2-D laparoscopy
2-D laparoscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Ultrasound appraisal of uterus weight \> 1000 gram
* Need for prolapse surgery and therefore indication for vaginal hysterectomy.
* Inability to give informed consent
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zealand University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elise Hoffmann
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sjaellands Univercety Hospital
Roskilde, Region Sjælland, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2D/3D hysterectomy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.