COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nathanson retractor

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.

Group Type ACTIVE_COMPARATOR

liver retraction Nathanson retractor

Intervention Type PROCEDURE

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

snake retractor

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.

Group Type ACTIVE_COMPARATOR

liver retraction snake retractor

Intervention Type PROCEDURE

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

fan retractor

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

Group Type ACTIVE_COMPARATOR

liver retraction fan retractor

Intervention Type PROCEDURE

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

CONTROL GROUP

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

Group Type ACTIVE_COMPARATOR

liver retraction laparoscopic grasper

Intervention Type PROCEDURE

laparoscopic grasper without any special tools

Interventions

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liver retraction Nathanson retractor

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

Intervention Type PROCEDURE

liver retraction snake retractor

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

Intervention Type PROCEDURE

liver retraction fan retractor

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

Intervention Type PROCEDURE

liver retraction laparoscopic grasper

laparoscopic grasper without any special tools

Intervention Type PROCEDURE

Other Intervention Names

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nathanson retractor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No