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Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04277065
Enrollment
88
Registered
2020-02-20
Start date
2020-03-01
Completion date
2022-09-01
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Liver Resection, Tourniquet, Vascular Occlusion

Keywords

Laproscopic hepatectomy, Bulldog, Vascular occlusion

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

Interventions

PROCEDUREBULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection

Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.

PROCEDUREcotton tourniquet

cotton tourniquet

Sponsors

hui hou
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Blood lossintraoperativethe volume of blood loss

Secondary

MeasureTime frameDescription
Postoperative complication(Rates in different grades)up to 30 days after liver resectionAccording to The Clavien-Dindo Classification,https://www.assessurgery.com/clavien-dindo-classification/
Mortality ratesup to 30 days after liver resectionthe rate of postoperative death
Hospital duration after operation (days)up to 30 days after liver resectionthe length of hospital stay
Operation time(min)intraoperativethe during of operation
Blood transfusion (times and units)intraoperativeintraoperative blood transfusion
Liver functional recoveryup to 7 days after liver resectionAST(glutamic oxalacetic transaminase, u/l)
Duration of abdominal drain (days)up to 14 days after liver resectionDuration of abdominal drain
Duration to first flatus (days)up to 14 days after liver resectionDuration to first flatus
Comfort questionnaire measures (GCQ) measures by Kolcabaup to 30 days after liver resectionGCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html
Intensive care unit stay(days)up to 7 days after liver resectionIntensive care unit stay in days
the clamping and declamping time(s)intraoperativethe clamping and declamping time of using bulldog or cotton

Countries

China

Contacts

Primary ContactLiang He, Master
heliang20062007@163.com13655600231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026