Tranexamic Acid Instillation in Laparoscopic Cholecystectomy

NCT06246422 | Completed

• 1 other identifier: TXA/08/2022
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients undergoing laparoscopic cholecystectomy are at high risk to develop postoperative bleeding especially in the presence of severe adhesions. Local instillation of the antifibrinolytic (tranexamic acid) at the gall bladder bed may decrease the risk of bleeding. The aim of this study is to evaluate the role of topical administration of Tranexamic acid on gallbladder bed for prophylaxis against bleeding in cases of difficult dissection cases due to acute inflammation and dense adhesions.

Conditions

Postoperative Complications

Keywords

gall bladder; postoperative bleeding; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Hematocrit concentration in the drain

  The level of hematocrit in the drain 6 h after surgery

  6 hours

Secondary Outcomes (2)

• Hemoglobin level in the drain

  6 hours

• Length of hospital stay.

  24 hours

Study Arms (2)

group A

EXPERIMENTAL

after careful hemostasis for the bleeding points in the liver bed received 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed through the right port, then introduction of a piece of gauze to keep the drug in place for about 3 minutes and then remove it and inserting a drain and close it for one hour after finishing the operation.

Drug: Tranexamic Acid 500 MG

group B

EXPERIMENTAL

they also underwent the same procedure with routine care for hemostasis until there was no significant bleeding and then instillation of 20 ml normal saline in the gallbladder bed , then drain was inserted and closed for 1 hour the sameway as group A.

Drug: Normal saline

Interventions

Tranexamic Acid 500 MG DRUG

Local instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed

group A

Normal saline DRUG

Local instillation of 20 ml normal saline in the gall bladder bed

group B

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 21-60 years that underwent laparoscopic cholecystectomy with intra-operative difficult dissection due to adhesions or acute inflammation.

You may not qualify if:

• Patients who will refuse participation in the study
• Patients with bleeding disorders, clotting abnormalities, or on anticoagulants therapy.
• Easy going operation that do not necessitate drain insertion.
• major bleeding that could necessitate surgical intervention to control.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Al Fayyum, 63512, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications; Postoperative Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the investigator will be kept blinded by the aid of closed sealed envelops. The measurements will be collected by the aid of assistant resident who will not participating into the study and blinded to it.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Prospective study

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: December 11, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

EG (1)