COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE

NCT03795844 | Completed

• 1 other identifier: ANIL ERGIN.......
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Damage

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Study Arms (4)

Nathanson retractor

ACTIVE COMPARATOR

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.

Procedure: liver retraction Nathanson retractor

snake retractor

ACTIVE COMPARATOR

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.

Procedure: liver retraction snake retractor

fan retractor

ACTIVE COMPARATOR

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

Procedure: liver retraction fan retractor

CONTROL GROUP

ACTIVE COMPARATOR

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

Procedure: liver retraction laparoscopic grasper

Interventions

liver retraction Nathanson retractor PROCEDURE

liver retractor will be used for the retraction of left lobe of liver

Also known as: nathanson retractor

Nathanson retractor

liver retraction snake retractor PROCEDURE

liver retractor will be used for the retraction of left lobe of liver

snake retractor

liver retraction fan retractor PROCEDURE

liver retractor will be used for the retraction of left lobe of liver

fan retractor

liver retraction laparoscopic grasper PROCEDURE

laparoscopic grasper without any special tools

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Anil ERGIN , General Surgery , Asistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)