Clinical trial · Interventional
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding | — | UNRESOLVED | — |
| Adenomyosis | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2D Laparoscopy | Device | — | UNRESOLVED |
| Storz 3D Laparoscopy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2D Laparoscopy
- description
- The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
- interventionNames
- Device: 2D Laparoscopy
- type
- ACTIVE_COMPARATOR
- label
- 3D laparoscopy
- description
- The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
- interventionNames
- Device: Storz 3D Laparoscopy System
Primary outcomes (1)
- measure
- Vaginal Cuff Closure Times
- timeFrame
- Start of vaginal cuff closure to end of vaginal cuff closure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding Exclusion Criteria: * None
References
Publications (4)
- BACKGROUNDBhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4. PMID 16985832
- BACKGROUNDTanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16. PMID 23072406
- BACKGROUNDEinarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70.
- DERIVEDAjao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6. PMID 31172324