Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

Study Overview
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Brief Summary
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LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, postoperative mortality, mobility and recovery of liver function are associated with major blood loss which is always the main cause of conversion to laparotomy and remains a challenge for surgeons. Pringle first described the method to arrest the hepatic hemorrhage by compression of the porta hepatis and this procedure was widely spread as well as in laparoscopic feild currently. Here, we described a new modified of Pringle maneuver using Bulldog to block vascular during LLR, and compared its effects with traditional pringle maneuver.

Detailed Description
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With the innovations of laparoscopic technique and specialized equipment , laparoscopic liver resection became the dominating resection surgery approach. December of 2014, laparoscopic hepatectomy was carried out in our department, extracorporeal Pringle maneuver has been applied in most laparoscopic liver resections which need to block the hepatic inflow, cotton tape was the frequently used tourniquet. We used to blocked the hepatic inflow by extracorporeal Pringle maneuver method with cotton tape for its validity , softness and no visible damages for vessel, but it was always difficult for clamping in a two-dimensional view to encircle the hepatoduodenal ligament , and it delayed operation time for freshmen. Bulldog has been widely used in urinary surgery for vascular occlusion, but bulldog in hepatic surgery has rarely been mentioned, this is the first report to formally demonstrate the clinical application in hepatic surgery. However, it is not clear that whether the bulldog for vascular occlusion is useful and easy to implement in laparoscopic hepatectomy. In this study, we will compare the cotton and the bulldog for vascular occlusion during laparoscopic hepatectomy

Official Title
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Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

Conditions
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Tourniquet, Laparoscopic Liver Resection, Vascular Occlusion

Intervention / Treatment
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* Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection
* Procedure: cotton tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for laparoscopic liver resection Child-Pugh A without portal hypertension No portosystemic shunt No previous abdominal operation history American society of anesthesiology class(ASA): I or II Age 18 to 80 Exclusion Criteria: Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others) Emergence hepatectomy Previous hepatectomy Combined operation for extrahepatic disease Vulnerable population (mental retardation, pregnancy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bulldog tourniquet in laparoscopic Hepatectomy<br>The bulldog tourniquet , a reusable vessel occlusion instrument forblocking the liver inflow-blood in laparoscopic liver resection, was uniformly employed in all patients randomized to Bulldog laparoscopic hepatectom group in the present study. | Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection<br>* Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.<br>|
| Active Comparator: cotton tourniquet in laparoscopic Hepatectomy<br>The cotton tourniquet ,a reusable vessel occlusion instrument for blocking the liver inflow-blood in laparoscopic liver resection | Procedure: cotton tourniquet<br>* cotton tourniquet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | the volume of blood loss | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver functional recovery | AST(glutamic oxalacetic transaminase, u/l) | up to 7 days after liver resection | 
| Postoperative complication(Rates in different grades) | According to The Clavien-Dindo Classification,https://www.assessurgery.com/clavien-dindo-classification/ | up to 30 days after liver resection | 
| Mortality rates | the rate of postoperative death | up to 30 days after liver resection | 
| Hospital duration after operation (days) | the length of hospital stay | up to 30 days after liver resection | 
| Operation time(min) | the during of operation | intraoperative | 
| Blood transfusion (times and units) | intraoperative blood transfusion | intraoperative | 
| the clamping and declamping time(s) | the clamping and declamping time of using bulldog or cotton | intraoperative | 
| Duration of abdominal drain (days) | Duration of abdominal drain | up to 14 days after liver resection | 
| Duration to first flatus (days) | Duration to first flatus | up to 14 days after liver resection | 
| Comfort questionnaire measures (GCQ) measures by Kolcaba | GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html | up to 30 days after liver resection | 
| Intensive care unit stay(days) | Intensive care unit stay in days | up to 7 days after liver resection | 
| Liver functional recovery | ALT(glutamic-pyruvic transaminase enzyme，u/l) | up to 7 days after liver resection | 
| Liver functional recovery | TB(total bilirubin，μmol/L) | up to 7 days after liver resection | 
| Liver functional recovery | ALB(albumin，g/L) | up to 7 days after liver resection | 
| Liver functional recovery | TP(total protein，g/L) | up to 7 days after liver resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laproscopic hepatectomy, Bulldog, Vascular occlusion