TriangleNCT02192606 · REGISTRY CONDITION SEARCH
Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- COMPLETED
- Registry last update
- 2018-01-24
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding Exclusion Criteria: * None
- healthy Volunteers
- true
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
- intervention Names
- Device: 2D Laparoscopy
- label
- 2D Laparoscopy
- type
- ACTIVE_COMPARATOR
- description
- The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
- intervention Names
- Device: Storz 3D Laparoscopy System
- label
- 3D laparoscopy
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- 3D laparoscopy
- description
- The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
- name
- Storz 3D Laparoscopy System
- type
- DEVICE
- arm Group Labels
- 2D Laparoscopy
- description
- The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
- name
- 2D Laparoscopy
- type
- DEVICE
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- SINGLE
- who Masked
- PARTICIPANT
- primary Purpose
- OTHER
Enrollment
- count
- 57
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
- measure
- Vaginal Cuff Closure Times
- time Frame
- Start of vaginal cuff closure to end of vaginal cuff closure
- secondary Outcomes
- description
- The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
- measure
- Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
- time Frame
- Time of Procedure End
Full study description
- brief 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.
- detailed Description
- This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.
Source references
- references
- citation
- Bhayani 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
- type
- BACKGROUND
- citation
- Tanagho 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
- type
- BACKGROUND
- citation
- Einarsson 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.
- type
- BACKGROUND
- citation
- Ajao 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-648c033428a23a12f970
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- end
- 11
- exact text
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- start
- 0
- offset unit
- unicode_code_points
- query cond
- Vaginal Cancer
- query disease state id
- ds-vaginal-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
- source file sha256
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- source string sha256
- ec2da448403fe1e7d83dc85102f713f85b93f16801e7e7c02f438d2b04f08136
Preserved source evidence · Not medical advice