Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy for Patients

Sponsor
hui hou (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04277065
Collaborator
(none)
88
1
2
30
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection
  • Procedure: cotton tourniquet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Blood loss [intraoperative]

    the volume of blood loss

Secondary Outcome Measures

  1. Liver functional recovery [up to 7 days after liver resection]

    AST(glutamic oxalacetic transaminase, u/l)

  2. 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/

  3. Mortality rates [up to 30 days after liver resection]

    the rate of postoperative death

  4. Hospital duration after operation (days) [up to 30 days after liver resection]

    the length of hospital stay

  5. Operation time(min) [intraoperative]

    the during of operation

  6. Blood transfusion (times and units) [intraoperative]

    intraoperative blood transfusion

  7. the clamping and declamping time(s) [intraoperative]

    the clamping and declamping time of using bulldog or cotton

  8. Duration of abdominal drain (days) [up to 14 days after liver resection]

    Duration of abdominal drain

  9. Duration to first flatus (days) [up to 14 days after liver resection]

    Duration to first flatus

  10. 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

  11. Intensive care unit stay(days) [up to 7 days after liver resection]

    Intensive care unit stay in days

  12. Liver functional recovery [up to 7 days after liver resection]

    ALT(glutamic-pyruvic transaminase enzyme,u/l)

  13. Liver functional recovery [up to 7 days after liver resection]

    TB(total bilirubin,μmol/L)

  14. Liver functional recovery [up to 7 days after liver resection]

    ALB(albumin,g/L)

  15. Liver functional recovery [up to 7 days after liver resection]

    TP(total protein,g/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The 2nd affiliated hospital of Anhui Medical University Hefei Anhui China 230601

Sponsors and Collaborators

  • hui hou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hui hou, Director of the hepatobiliary surgery department, The Second Hospital of Anhui Medical University
ClinicalTrials.gov Identifier:
NCT04277065
Other Study ID Numbers:
  • 1234
First Posted:
Feb 20, 2020
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hui hou, Director of the hepatobiliary surgery department, The Second Hospital of Anhui Medical University

Study Results

No Results Posted as of Feb 20, 2020