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Liga Sure Versus Conventional Suture Ligature for Decrease Blood Loss During Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT03505333
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Decrease Blood Loss During Abdominal Hysterectomy Procedure: conventional suture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blinded randomized trials
Masking: Single (Participant)
Masking Description: Patients were randomized to two groups according to a two-blocked randomization list which was coded (a) or (b) at 1:1 ratio. The two parallel groups were prepared using a Computer-generated randomization system. The allocated groups were concealed in serially numbered sealed opaque envelopes that were opened only after recruitment. Patient allocation was performed prior to the induction of anesthesia by an independent researcher, who was not otherwise being involved in this study. The trial was appropriately single-blinded. The participants were blinded to the procedure performed.
Primary Purpose: Treatment
Official Title: Liga Sure Versus Conventional Suture Ligature for Decrease Blood Loss During Abdominal Hysterectomy: Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: conventional suture ligature
use of conventional sutures for hysterectomy
Procedure: conventional suture
we use Liga-sure device for hysterectomy

Active Comparator: Liga Sure
use of conventional sutures plus use of Liga-sure for hysterectomy
Procedure: conventional suture
we use Liga-sure device for hysterectomy




Primary Outcome Measures :
  1. decrease blood loss during hysterectomy [ Time Frame: intra-operative ]
    Blood loss well be estimated by a combination of direct measurement and gravimetric method


Secondary Outcome Measures :
  1. need for blood transfusion, [ Time Frame: intraoperative ]
    number RBC unit trasfused

  2. post operative HB [ Time Frame: 24 hour post operative ]
    measure HB pos operative

  3. operative time [ Time Frame: intra operative ]
    time of operation



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient prepared for an elective benign hysterectomy

Exclusion Criteria:

  1. Patients with a cardiac, hepatic, renal or thromboembolic disease.
  2. patients with pelvic endometriosis and adnexal mass.
  3. patients with endometrial or cervical cancer
  4. radical hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505333


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w shady, md 01092440504 ext 002 nahlagyn@yahoo.com

Locations
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Egypt
AswanUH Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, md    01022336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla w Shady, md    0101092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, lecturer, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03505333     History of Changes
Other Study ID Numbers: aswu/202/18
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes