NCT03505333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

April 7, 2018

Last Update Submit

January 6, 2020

Conditions

Decrease Blood Loss During Abdominal Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • decrease blood loss during hysterectomy

    Blood loss well be estimated by a combination of direct measurement and gravimetric method

    intra-operative

Secondary Outcomes (3)

  • need for blood transfusion,

    intraoperative

  • post operative HB

    24 hour post operative

  • operative time

    intra operative

Study Arms (2)

conventional suture ligature

EXPERIMENTAL

use of conventional sutures for hysterectomy

Procedure: conventional suture

Liga Sure

ACTIVE COMPARATOR

use of conventional sutures plus use of Liga-sure for hysterectomy

Procedure: conventional suture

Interventions

conventional suturePROCEDURE

we use Liga-sure device for hysterectomy

Liga Sureconventional suture ligature

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient prepared for an elective benign hysterectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

Location

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-blinded randomized trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 23, 2018

Study Start

January 1, 2018

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

EG(1)