CompletedNot Applicable

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

Egypt90 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range

20 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

decrease blood loss during hysterectomy

Timeframe: intra-operative

Trial details

NCT IDNCT03505333

SponsorAswan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-30

View on ClinicalTrials.gov More Decrease Blood Loss During Abdominal Hysterectomy trials