Clinical trial NCT03088683: Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy
Official title: Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy: A Prospective Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: sleeve gastrectomy
liver retractor
nathanson
reveel
liver trauma
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* patients with BMI\>35

Exclusion Criteria:

* patients with known liver disease

Primary outcomes:
measure: Changes in physiological parameters of liver due to trauma of retractors
timeFrame: within the first 2 days of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nazif Bagriacik Kadioy Hospital
state: Kadikoy
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Abdullah Sisik
role: PRINCIPAL_INVESTIGATOR
References: