Sponsor study identifier
interventional
90
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
September 30, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)Liga Sure represents a novel principle for hemostatic sealing of vessel-containing tissue based on feedback-programmed dosage of bipolar diathermy.(5) According to marketing of the device, Liga Sure has the potential to replace the use of conventional suture ligature within a broad range of surgical procedures, also including removal of the uterus. While the use of Liga Sure has been critically assessed for a range of procedures such as hemorrhoidectomy, splenectomy, bile duct, urological and gastric operations,(6-12) a similar scientific evaluation of its suitability for abdominal removal of the uterus is lacking in the literature. The most promising aspect of Liga Sure in hysterectomy is the potential shorter operation time and decrease blood loss. Because removal of the uterus traditionally is the most frequently performed major gynecological operation,(13) the introduction of a time-sparing new technique could have significant impact on resource consumption. The aim of the study: we aimed at evaluating the use of Liga Sure compared with conventional suture ligature during abdominal hysterectomy, in a prospective randomized controlled trial with special emphasis on the safety, the duration of the procedure and the amount of blood loss.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)April 7, 2018
Actual (reported)April 23, 2018
Actual (reported)September 30, 2019
Actual (reported)December 30, 2019
Actual (reported)decrease blood loss during hysterectomy
Blood loss well be estimated by a combination of direct measurement and gravimetric method
intra-operative
need for blood transfusion,
intraoperative
post operative HB
24 hour post operative
operative time
intra operative
use of conventional sutures for hysterectomy
use of conventional sutures plus use of Liga-sure for hysterectomy
we use Liga-sure device for hysterectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
AswanUH
Aswān, 81528, Egypt
hany f sallam, md
Aswan University Hospital
90 participants (actual enrollment reported by the registry).
First Submitted
April 7, 2018
Contact the study team to confirm eligibility.
First Posted
April 23, 2018
Study Start
January 1, 2018
Actual (reported)Primary Completion
September 30, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)Last Updated
January 7, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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