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Trial record 88 of 183 for:    RET

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
Sponsor:
Information provided by (Responsible Party):
Abdullah Sisik, Umraniye Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Nathanson Retractor Device: Reveel Retractor Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with BMI>35

Exclusion Criteria:

  • patients with known liver disease

Information from the National Library of Medicine

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


Contacts
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Contact: Abdullah Sisik 00905062623325 abdullahsisik@gmail.com

Locations
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Turkey
Nazif Bagriacik Kadioy Hospital Recruiting
Istanbul, Kadikoy, Turkey
Contact: Abdullah Sisik    00905062623325    abdullahsisik@gmail.com   
Sub-Investigator: Hasan Erdem         
Sponsors and Collaborators
Umraniye Education and Research Hospital
Investigators
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Principal Investigator: Abdullah Sisik Umraniye Education and Research Hospital

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Responsible Party: Abdullah Sisik, General Surgery Specialist, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03088683     History of Changes
Other Study ID Numbers: COMP-LIV-RET
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Abdullah Sisik, Umraniye Education and Research Hospital:
sleeve gastrectomy
liver retractor
nathanson
reveel
liver trauma
Additional relevant MeSH terms:
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Wounds and Injuries
Liver Extracts
Hematinics