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Spots Global Cancer Trial Database for Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

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Trial Identification

Brief Title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

Official Title: Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? A Randomized Controlled Trial Comparing 3D Laparoscopy Versus Standard Laparoscopy

Study ID: NCT02192606

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Brigham & Women's Hospital, Boston, Massachusetts, United States

Odense University Hospital, Odense, , Denmark

Contact Details

Name: Jon Einarsson, MD, PhD, MPH

Affiliation: Brigham and Women's Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Sarah L Cohen, MD, MPH

Affiliation: Brigham and Women's Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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