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NCT02192606 · OUTCOME

Vaginal Cuff Closure Times

Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? · Source last updated 2018-01-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
minutes
Interval / dispersion
Standard Deviation
Time frame
Start of vaginal cuff closure to end of vaginal cuff closure

What was measured

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.

Groups in this outcome

2D Laparoscopy

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
2D Laparoscopy29
3D Laparoscopy28

Reported measurements

Source class 1
Values in minutes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
2D Laparoscopy10.175.98Not reportedNot reportedNot reported
3D Laparoscopy12.546.99Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.98
        value
        10.17
      2. group Id
        OG001
        spread
        6.99
        value
        12.54
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      28
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. description
    The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy 2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
    id
    OG000
    title
    2D Laparoscopy
  2. description
    The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. 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.
    id
    OG001
    title
    3D Laparoscopy
param Type
MEAN
reporting Status
POSTED
time Frame
Start of vaginal cuff closure to end of vaginal cuff closure
title
Vaginal Cuff Closure Times
type
PRIMARY
unit Of Measure
minutes

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice