Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy

Bariatric Surgery Clinical Trial

Official title: Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial

Status Completed

Clinical Trial Summary

Enhanced recovery after bariatric surgery imposes a significant reduction in length of hospital stay. However beneficial for the overall recovery it reduces the hospital observation time. after a laparoscopic surgery during which one of the longest resection line in surgery or anastomosis are created. Therefore, discovering possible safe and effective ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.

Clinical Trial Description

Aim:

To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeriessleeve gastrectomy operation.

Material and methods:

A single-blind randomized clinical trial in the high-volume bariatric center of excellence.

Patients undergoing highly standardized bariatric procedures, meeting the inclusion and exclusion criteria were included in the study, sample size determined by power study evaluation.

Randomization scheme was a weekly surgery schedule. Patients were randomized to 2 groups: TXA (administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced) od CG (no tranexamic acid administration).

Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.

1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications. ;

Related Conditions & MeSH terms

• Bariatric Surgery
• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage, Surgical
• Tranexamic Acid

• NCT number: NCT06038981
• Study type: Interventional
• Source: Medical University of Gdansk
• Status: Completed
• Phase: N/A
• Start date: July 4, 2022
• Completion date: June 28, 2023