Tranexamic Acid Instillation in Laparoscopic Cholecystectomy
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

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.
    

Intervention name(s): Tranexamic Acid 500 MG; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Local instillation of 500 mg tranexamic acid in 20 ml normal saline in the gall bladder bed; Local instillation of 20 ml normal saline in the gall bladder bed
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: gall bladder; postoperative bleeding; tranexamic acid