Tranexamic Acid Instillation in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Drug: Tranexamic Acid 500 MG; Drug: Normal saline

• Registration Number: NCT06246422
• Lead Sponsor: Tanta University

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.

Detailed 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.

Study Timeline

• Study Start: 2021-12-11
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Tranexamic Acid 500 MG	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.
group B	Normal saline	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.

Primary Outcome Measures

Name	Time	Method
Hematocrit concentration in the drain	6 hours	The level of hematocrit in the drain 6 h after surgery

Secondary Outcome Measures

Name	Time	Method
Hemoglobin level in the drain	6 hours	The hemoglobin concentration in the drain 6 h after surgery
Length of hospital stay.	24 hours	Time from admission to discharge of the patient

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Fayoum, Egypt