Trial Outcomes & Findings for Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy (NCT NCT02065453)

Last Updated: 2017-06-14

Results Overview

duration of surgery

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.

Results posted on

2017-06-14

Participant milestones
Measure	Disposable Device - Left & Reusable Devices - Right 27 women were randomized to attending physicians using the disposable device on the left and reusable devices on the right.	Disposable Device - Right & Reusable Devices - Left 25 women were randomized to attending physicians using the disposable device on the right and reusable devices on the left
Overall Study STARTED	27	25
Overall Study COMPLETED	24	21
Overall Study NOT COMPLETED	3	4

Withdrawal data not reported

Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

Baseline characteristics by cohort
Measure	Disposable Device Left and Resusable Devices Right n=24 Participants 27 women were randomized to receive disposable device left and resusable devices right	Disposable Device Right and Reusable Devices Left n=21 Participants 25 women were randomized to receive disposable device right and reusable devices left	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants	21 Participants n=4 Participants	45 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	39 years n=93 Participants	39 years n=4 Participants	39 years n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	21 Participants n=4 Participants	45 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	24 participants n=93 Participants	21 participants n=4 Participants	45 participants n=27 Participants

Timeframe: Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.

Population: Uterine Vessel Desiccation and Electrosurgical Cutting Time (min)

duration of surgery

Outcome measures
Measure	Disposable n=45 Participants Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined	Reusable n=45 Participants Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side	8.4 minutes Interval 8.4 to 8.7	14.6 minutes Interval 12.5 to 16.7

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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