UnknownPhase 3

Effectiveness of the Use of the New Hemostatic Patch Hemopatch ® in Patients Undergoing Surgical Liver Resection

Spain250 participantsStarted 2016-05

Plain-language summary

This prospective randomized study aims to determine the influence of the use of local hemostatic on the incidence of local complications derived from the edge of transection: biliary fistula or bleeding, after scheduled hepatic resection.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion Criteria: * Scheduled major or minor liver resection surgery by laparotomy approach. * Age\>18 * They have given their written consent voluntarily after having offered the possibility of their participation in the study. Exclusion Criteria: * Pregnancy and lactation * Patients with urgent surgery * Concomitant surgery of another organ * Gallbladder or biliary-enteric anastomosis associated. * ALPPS surgery (stands for Associating Liver Partition and Portal vein Ligation for Staged hepatectomy). * Patients with liver transplantation history. * Patients with previous liver trauma. * Patients with congenital haematological disease involving clotting factors alteration. * Patients with known hypersensitivity to bovine proteins and brilliant blue colorante (FD\&C Nº1).

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

Bleeding

Timeframe: Day 0 to day 30 (+-10 days)

Presence of Biliary Fistula

Timeframe: Day 0 to day 30 (+-10 days)

Trial details

NCT IDNCT02769754

SponsorInstituto de Investigacion Sanitaria La Fe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

Contact for this trial

Elena García

0034961246611 investigacion_clinica@iislafe.es

View on ClinicalTrials.gov More Liver Damage trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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