Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

February 18, 2020 updated by: hui hou

Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The 2nd affiliated hospital of Anhui Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bulldog tourniquet in laparoscopic Hepatectomy
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
Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.
ACTIVE_COMPARATOR: cotton tourniquet in laparoscopic Hepatectomy
The cotton tourniquet ,a reusable vessel occlusion instrument for blocking the liver inflow-blood in laparoscopic liver resection
Procedure: cotton tourniquet
cotton tourniquet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

hui hou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1234 (Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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