Trial Outcomes & Findings for Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy (NCT NCT00746018)

Last Updated: 2018-04-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

conclusion of the study

Results posted on

2018-04-11

Participant milestones
Measure	Total Hysterectomy The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
Overall Study STARTED	39
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy

Baseline characteristics by cohort
Measure	Total Hysterectomy n=39 Participants The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants

Timeframe: conclusion of the study

Population: Data were not collected

Outcome data not reported

Serious events: 0 serious events

Other events: 34 other events

Deaths: 4 deaths

Adverse event data not reported

Other adverse events
Measure	Total Hysterectomy n=39 participants at risk The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
Metabolism and nutrition disorders Hyperglycemia	82.1% 32/39 • 1 year
Blood and lymphatic system disorders Hemoglobin	56.4% 22/39 • 1 year
Metabolism and nutrition disorders Hypoalbuminemia	46.2% 18/39 • 1 year
Investigations Aspartate Aminotransferase (AST) Test	17.9% 7/39 • 1 year
Investigations Alanine Aminotransferase (ALT) Test	15.4% 6/39 • 1 year
Investigations Lymphopenia	15.4% 6/39 • 1 year
Metabolism and nutrition disorders Hypokalemia	15.4% 6/39 • 1 year
Investigations INR	12.8% 5/39 • 1 year
Investigations Platelets	12.8% 5/39 • 1 year
Metabolism and nutrition disorders Hyponatremia	12.8% 5/39 • 1 year
Metabolism and nutrition disorders Hypoglycemia	10.3% 4/39 • 1 year
Metabolism and nutrition disorders Hypophosphatemia	10.3% 4/39 • 1 year
Metabolism and nutrition disorders Hyperkalemia	10.3% 4/39 • 1 year
Metabolism and nutrition disorders Hypernatremia	10.3% 4/39 • 1 year
Investigations Alkaline phosphatase	5.1% 2/39 • 1 year
Metabolism and nutrition disorders Bicarbonate, serum-low	5.1% 2/39 • 1 year
Investigations Creatinine	5.1% 2/39 • 1 year

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