Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy
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|ClinicalTrials.gov Identifier: NCT03088683|
Recruitment Status : Unknown
Verified March 2017 by Abdullah Sisik, Umraniye Education and Research Hospital.
Recruitment status was: Recruiting
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: Nathanson Retractor Device: Reveel Retractor||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy: A Prospective Multicenter Clinical Trial|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 1, 2017|
|Estimated Study Completion Date :||April 20, 2017|
Active Comparator: Nathanson Retractor
Nathanson retractor will be used
Device: Nathanson Retractor
Liver will be retracted with Nathanson retractor
Active Comparator: Reveel Retractor
Reveel retractor will be used
Device: Reveel Retractor
Liver will be retracted with Reveel retractor
- Changes in physiological parameters of liver due to trauma of retractors [ Time Frame: within the first 2 days of the surgery ]Traumatic effects of liver retractors in sleeve gastrectomy. Number of participants with abnormal laboratory values.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088683
|Contact: Abdullah Sisikemail@example.com|
|Nazif Bagriacik Kadioy Hospital||Recruiting|
|Istanbul, Kadikoy, Turkey|
|Contact: Abdullah Sisik 00905062623325 firstname.lastname@example.org|
|Sub-Investigator: Hasan Erdem|
|Principal Investigator:||Abdullah Sisik||Umraniye Education and Research Hospital|