Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088683
• Other study ID #: COMP-LIV-RET
• Status: Recruiting
• Phase: N/A
• First received: January 16, 2017
• Last updated: March 16, 2017
• Start date: January 2017
• Est. completion date: April 20, 2017

Study information

• Verified date: March 2017
• Source: Umraniye Education and Research Hospital
• Contact: Abdullah Sisik
• Phone: 00905062623325
• Email: abdullahsisik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 20, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with BMI>35

Exclusion Criteria:

• patients with known liver disease

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Nathanson Retractor
Liver will be retracted with Nathanson retractor
• Reveel Retractor
Liver will be retracted with Reveel retractor

Locations

Country	Name	City	State
Turkey	Nazif Bagriacik Kadioy Hospital	Istanbul	Kadikoy

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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