Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

Not Applicable

• Conditions: Laparoscopic Liver Resection; Vascular Occlusion; Tourniquet
• Interventions: Procedure: cotton tourniquet; Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection

• Registration Number: NCT04277065
• Lead Sponsor: hui hou

Brief Summary

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

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

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20
• Study Start: 2020-03-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cotton tourniquet in laparoscopic Hepatectomy	cotton tourniquet	The cotton tourniquet ,a reusable vessel occlusion instrument for blocking the liver inflow-blood in laparoscopic liver resection
Bulldog tourniquet in laparoscopic Hepatectomy	BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection	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.

Primary Outcome Measures

Name	Time	Method
Blood loss	intraoperative	the volume of blood loss

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The 2nd affiliated hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China