Tranexamic Acid Instillation in Laparoscopic Cholecystectomy

Postoperative Complications Clinical Trial

Official title:

The Effect of Local Instillation of Tranexamic Acid on the Gallbladder Bed After Laparoscopic Cholecystectomy to Decrease Possible Bleeding: Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06246422
• Other study ID #: TXA/08/2022
• Status: Completed
• Phase: N/A
• Start date: December 11, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective study will be conducted in 80 adult patients admitted to surgery department Tanta University, the study will be carried out over 6 months after obtaining ethical committee approval, an informed written consent will be included.

Any unexpected risk that will appear during the procedure will be announced to the participants and ethical committee at time and adequate measures will be taken.

Risk to the patients There is known risk to the patient except for rare possible allergy to the drug.

All participant surgeons are experienced and familiar with the field. There will be adequate supervision to maintain the privacy of patients and confidentiality.

There will be no conflict of interest nor conflict with religion, law or society standards.

End point of study This study will be terminated if there is any unexpected risk from the drug.

This is a prospective study performed on 80 patients suffering from symptomatic cholelithiasis and will undergo laparoscopic cholecystectomy, they will be divided into two groups randomly by slip method. And will be performed by experienced surgeons.

All patients were subjected to:

Detailed history including drug intake (anticoagulants or antiplatelets) and thorough clinical examination.

laboratory investigations complete blood count (CBC), C-reactive protein (CRP), fasting blood sugar, renal function tests, and abdominal ultrasonography done.

Operative procedure After applying general anaesthesia , standard 4 port laparoscopic cholecystectomy will be performed. Patients in group A (40 patients) will receive 500 mg of Tranexamic acid dissolved in 20 ml normal saline locally in the liver bed after completing the procedure, we will introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and we will insert a drain and close it for one hour after finishing the operation, if there is easy going operation without any adhesions and very minimal risk for bleeding it will be excluded.

For group B (40 patients) they will also undergo the same procedure with routine care that there is no significant bleeding then instillation of 20 ml normal saline locally in the liver bed and introduce a piece of gauze to keep the drug in place for about 3 minutes and then remove it and drain will be inserted for difficult cases and also easy ones will be excluded.

Post operative care Heart rate and blood pressure will be checked every 6 hours after surgery. Drain output will be recorded drain fluid hematocrit and hemoglobin will be investigated after 6 hours and 24 hours, and all the patients will be followed up till discharged. Drain will be removed if less than 50 cc for 24 hours.

Hb level will be performed after 48 h and was compared with the preoperative levels.

Any possible morbidity and time for ambulation and hospital stay will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Drug:
• Tranexamic Acid 500 MG
Local instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed
• Normal saline
Local instillation of 20 ml normal saline in the gall bladder bed

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematocrit concentration in the drain	The level of hematocrit in the drain 6 h after surgery	6 hours
Secondary	Hemoglobin level in the drain	The hemoglobin concentration in the drain 6 h after surgery	6 hours
Secondary	Length of hospital stay.	Time from admission to discharge of the patient	24 hours