Does 3D Laparoscopy Improve Vaginal Cuff Suture Time?

NCT ID: NCT02192606

Last Updated: 2018-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Uterine Fibroids Abnormal Uterine Bleeding Pelvic Pain Adenomyosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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2D Laparoscopy

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

Group Type ACTIVE_COMPARATOR

2D Laparoscopy

Intervention Type DEVICE

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

3D laparoscopy

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

Group Type ACTIVE_COMPARATOR

Storz 3D Laparoscopy System

Intervention Type 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.

Interventions

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Storz 3D Laparoscopy System

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.

Intervention Type DEVICE

2D Laparoscopy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jon I. Einarsson

Division Chair, Minimally Invasive Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Einarsson, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Sarah L Cohen, MD, MPH

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

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Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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United States Denmark

References

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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.

Reference Type BACKGROUND
PMID: 16985832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23072406 (View on PubMed)

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.

Reference Type 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.

Reference Type DERIVED
PMID: 31172324 (View on PubMed)

Other Identifiers

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3DRCT

Identifier Type: -

Identifier Source: org_study_id

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