Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
In Laparoscopic Sleeve Gastrectomy, retraction of the left lobe of the liver is important for an effective visualisation. There are many retractors available for this retraction. A study is designed to compare two different liver retractors for liver trauma; Nathanson liver retractor that is used more commonly and Reveel liver retractor that has more recent history of use.

Detailed Description
-----------------
A randomised controlled prospective study is designed with 80 patients over 3-month period (January 2017 to March 2017). Laparoscopic sleeve gastrectomy is planned for all patients. Two groups are designed depending on retractor. Liver retraction will be provided with Nathanson retractor in first group (Nathanson group, 40 patients), and with Reveel retractor in second group (Reveel group, 40 patients). Preoperative serum levels of transaminases, total bilirubin and C-reactive protein will be measured in all patients. The same biochemical markers will be measured on days 1 and 2 postoperatively. The patients with body mass index (BMI) ≥35kg/m2 are enrolled to study. The parameters of demographic characteristics (age, gender, BMI, weight, and body fat percentage), and clinical outcomes (postoperative complications, mortality, readmissions) are planned to record. Operative Technique All patients will be operated by same surgeons. and anesthetist. Peroperatively intravenous paracetamol 10 mg, tramadol 50 mg and fentanyl 150 mcg will be used for analgesia. Laparoscopic sleeve gastrectomy will be performed with 5 trocars, in reverse trendelenburg position by creating pneumoperitoneum with 14 mmHg carbon dioxide insufflation. Trocar replacements are one 10-mm trocar in the midline above umbilicus for the endoscope, one 12-mm trocar to right midclavicular line linage to the 10-mm trocar. One 5-mm trocar to the left midclavicular line linage to the 10-mm trocar, one 5-mm trocar to the front axillary line below the left costal margin. Both liver retractors will be placed from 2 cm below the xiphoid process for liver retractor. In nathanson group; after placing the blade of Nathanson retractor below the left lobe of the liver, it will be fixed to the operating table by the other instruments of retractor. In reveel group; the retractor will be placed below the left lobe of the liver and then it will be fixed to the skin with a towel clamp. 38 F orogastric tube will be used. No use of nasogastric tubes and urinary catheters routinely is planned. Drain replacement is planned for all patients. Preoperative and postoperative values of the markers will be analysed and compared between two groups.

Official Title
-----------------
Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy: A Prospective Multicenter Clinical Trial

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Nathanson Retractor
* Device: Reveel Retractor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with BMI>35 Exclusion Criteria: patients with known liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nathanson Retractor<br>Nathanson retractor will be used | Device: Nathanson Retractor<br>* Liver will be retracted with Nathanson retractor<br>|
| Active Comparator: Reveel Retractor<br>Reveel retractor will be used | Device: Reveel Retractor<br>* Liver will be retracted with Reveel retractor<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physiological parameters of liver due to trauma of retractors | Traumatic effects of liver retractors in sleeve gastrectomy. Number of participants with abnormal laboratory values. | within the first 2 days of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleeve gastrectomy, liver retractor, nathanson, reveel, liver trauma