ClinicalTrials.Veeva

Menu

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

Mass General Brigham logo

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

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

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

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems