Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? (3DRCT)

Mass General Brigham

Status: Completed

Conditions: Uterine Fibroids; Pelvic Pain; Adenomyosis; Abnormal Uterine Bleeding

Treatments: Device: Storz 3D Laparoscopy System; Device: 2D Laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02192606

3DRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

2D Laparoscopy

Active Comparator group

Description:

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

Treatment:

Device: 2D Laparoscopy

3D laparoscopy

Active Comparator group

Description:

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

Treatment:

Device: Storz 3D Laparoscopy System