N/A
N=57
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Uterine Fibroids · Abnormal Uterine Bleeding · Pelvic Pain · Adenomyosis
Bottom Line
View on ClinicalTrials.gov: NCT02192606 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Vaginal Cuff Closure Times — 10.17; 12.54 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Storz 3D Laparoscopy System (Device); 2D Laparoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaginal Cuff Closure Times |
10.17; 12.54 | — |
| SECONDARY Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy |
55.74; 60.83 | — |
Summary
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Eligibility Criteria
Inclusion Criteria
- Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02192606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.