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COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE (RETRACTOR)

Primary Purpose

Liver Damage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
liver retraction Nathanson retractor
liver retraction snake retractor
liver retraction fan retractor
liver retraction laparoscopic grasper
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Damage

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy

Exclusion Criteria:

  • The patients with liver failure
  • The patients with impaired preoperative liver function tests
  • The patients who have been diagnosed with any liver disease
  • The patients with bleeding disorders

Sites / Locations

  • Fatih Sultan Mehmet Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nathanson retractor

snake retractor

fan retractor

CONTROL GROUP

Arm Description

Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved.

Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved.

Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus

Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools

Outcomes

Primary Outcome Measures

Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.
measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2019
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03795844
Brief Title
COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE
Acronym
RETRACTOR
Official Title
COMPARISON OF LIVER RETRACTOR USED IN LAPAROSCOPIC SLEEVE GASTRECTOMY BY INTRAOPERATIVE LIVER DAMAGE
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries, the liver masses are also found to be significantly larger due to the high Body Mass Index scores. It is known that the application of a diet called liver shrinkage protein diet which is applied preoperatively is a method that contributes to the comfort of the surgeon during surgery by reducing the size of the liver. The large size of the liver narrows the field of view of the surgeon in operation and decreases the comfort of surgery. One of the most important points that the surgeon must solve during surgery is the exclusion of the left lobe of the liver. The most commonly used types of liver retractors today; Nathanson retractor, Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other retractors. Some of these retractors require an additional incision under xiphoid, which may lead to an injury risk. The installation of these retractors also increases the operation time and requires additional time. Numerous studies have shown that retractors, which are used to rule out liver left lobe during surgery, cause liver damage. However, in order to reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is mandatory. Therefore, it is necessary to determine and use the retractor type which causes the least damage between the liver retractors. In our study, it was aimed to reveal three types of liver retractors in our hospital in different cases and to reveal the type of trocar that causes the least amount of liver damage.
Detailed Description
During laparoscopic upper abdominal surgery, the operative view is usually blocked by the left lobe of the liver. An effective liver retraction is important for good vision and safety during operation. In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined with postoperative first day abdominal abdomen magnetic resonance imaging and the liver injury will be evaluated by the radiologist. Patients will not know which liver excision method is used during surgery. The radiologist who will perform damage assessment on imaging will not know which type of liver dislocation is used. Therefore, the study will be planned as double blind. The liver excision method will be applied sequentially. Randomization will be done in this way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Damage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nathanson retractor
Arm Type
Active Comparator
Arm Description
Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved.
Arm Title
snake retractor
Arm Type
Active Comparator
Arm Description
Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved.
Arm Title
fan retractor
Arm Type
Active Comparator
Arm Description
Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools
Intervention Type
Procedure
Intervention Name(s)
liver retraction Nathanson retractor
Other Intervention Name(s)
nathanson retractor
Intervention Description
liver retractor will be used for the retraction of left lobe of liver
Intervention Type
Procedure
Intervention Name(s)
liver retraction snake retractor
Intervention Description
liver retractor will be used for the retraction of left lobe of liver
Intervention Type
Procedure
Intervention Name(s)
liver retraction fan retractor
Intervention Description
liver retractor will be used for the retraction of left lobe of liver
Intervention Type
Procedure
Intervention Name(s)
liver retraction laparoscopic grasper
Intervention Description
laparoscopic grasper without any special tools
Primary Outcome Measure Information:
Title
Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.
Description
measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy Exclusion Criteria: The patients with liver failure The patients with impaired preoperative liver function tests The patients who have been diagnosed with any liver disease The patients with bleeding disorders
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE

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