The Effect of Local Instillation of Tranexamic Acid on the Gallbladder Bed After Laparoscopic Cholecystectomy to Decrease Possible Bleeding: Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Hematocrit concentration in the drain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 21-60 years that underwent laparoscopic cholecystectomy with intra-operative difficult dissection due to adhesions or acute inflammation.
排除标准
- •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.
研究组 & 干预措施
group A
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.
干预措施: Tranexamic Acid 500 MG (Drug)
group B
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.
干预措施: Normal saline (Drug)
结局指标
主要结局
Hematocrit concentration in the drain
时间窗: 6 hours
The level of hematocrit in the drain 6 h after surgery
次要结局
- Hemoglobin level in the drain(6 hours)
- Length of hospital stay.(24 hours)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University