Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03795844 |
| Other study ID # |
ANIL ERGIN....... |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
February 1, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Fatih Sultan Mehmet Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
