Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

NCT02192606 | Completed Results

• 1 other identifier: 3DRCT
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 2

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.

Conditions

Uterine Fibroids; Abnormal Uterine Bleeding; Pelvic Pain; Adenomyosis

Keywords

Laparoscopy; 3D Visual System; Total Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Vaginal Cuff Closure Times

  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.

  Start of vaginal cuff closure to end of vaginal cuff closure

Secondary Outcomes (1)

• Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy

  Time of Procedure End

Study Arms (2)

2D Laparoscopy

ACTIVE COMPARATOR

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy

Device: 2D Laparoscopy

3D laparoscopy

ACTIVE COMPARATOR

The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.

Device: Storz 3D Laparoscopy System

Interventions

Storz 3D Laparoscopy System DEVICE

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.

3D laparoscopy

2D Laparoscopy DEVICE

The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.

2D Laparoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Leiomyoma; Metrorrhagia; Pelvic Pain; Adenomyosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Jon I. Einarsson
• Organization: Brigham and Women's Hospital

jeinarsson@partners.org

617-732-5500

Study Officials

• Jon Einarsson, MD, PhD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Sarah L Cohen, MD, MPH

  Brigham and Women's Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chair, Minimally Invasive Gynecology

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: July 17, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 24, 2018
• Results First Posted: October 6, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); US (1)