CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
disposable device (Ligasure, Covidien) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02065453
NCT02065453N/ACompleted

Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

St. Louis University·interventional·Posted Feb 19, 2014·Updated Jun 14, 2017

In Brief

A clinical study evaluating disposable device (Ligasure, Covidien) and Reusable device for Benign Uterine Disease. Completed, enrolled 52 participants across 1 site.

Detailed Summary

Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are accomplished laparoscopically in the investigators current surgical practice to allow women a quicker recovery than a traditional large incision. Disposable laparoscopic devices have been developed to assist in the completion of hysterectomies. These disposable energy sources are only used once, but offer an improved safety and energy profile in that they reliably control bleeding with little damage to surrounding tissue and potentially save time. Reusable energy instruments can be sterilized and reused for multiple cases. Operating room time is expensive. The investigators calculate that if 6.7 minutes of time can be saved using the disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz Laparoscopic Shears, the time savings could justify the cost of the device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2014
Enrollment StartJan 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.4 years ago

Interventions

disposable device (Ligasure, Covidien)device

One side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien). . We will randomize the side for each energy source used on each side for every case. The number of "sides" performed by the attending surgeon will equal that of the less experienced resident surgeon.

Reusable devicedevice

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic