ObesityNCT03088683
Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy
A study testing Nathanson Retractor and Reveel Retractor in people with Obesity, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nathanson Retractor and Reveel Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with BMI>35
Who cannot join
- patients with known liver disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nazif Bagriacik Kadioy Hospital
Istanbul, Kadikoy
Abdullah Sisik, 00905062623325, abdullahsisik@gmail.com
Hasan Erdem
About this study
Official title: Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy: A Prospective Multicenter Clinical Trial
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Nathanson Retractor, Reveel Retractor
- Keywords
- sleeve gastrectomy, liver retractor, nathanson, reveel, liver trauma
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nathanson RetractorDevice
Liver will be retracted with Nathanson retractor
Reveel RetractorDevice
Liver will be retracted with Reveel retractor
| Study group | Role | What they receive |
|---|---|---|
| Nathanson Retractor | Active comparator | Nathanson retractor will be used Receives: Device: Nathanson Retractor |
| Reveel Retractor | Active comparator | Reveel retractor will be used Receives: Device: Reveel Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 2 days of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startJan 2017
- Primary completion1 Apr 2017 (estimated)
- Study completion20 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Sisik, Umraniye Education and Research Hospital
- Investigators
- Abdullah Sisik, Principal investigator, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088683
- Sponsor's protocol ID
- COMP-LIV-RET
- Status last verified
- Mar 2017
- First submitted
- 16 Jan 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Liver Trauma in Two Retractors Used in Sleeve Gastrectomy: A Prospective Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03088683
- Acronym / sponsor ID
- COMP-LIV-RET
- Conditions
- Obesity
- Keywords
- sleeve gastrectomy, liver retractor, nathanson, reveel, liver trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2017
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 20 Apr 2017 (estimated)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nathanson Retractor | Active comparator | Device: Nathanson RetractorNathanson retractor will be used |
| Reveel Retractor | Active comparator | Device: Reveel RetractorReveel retractor will be used |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with BMI>35
Key exclusion criteria (1 listed)
- patients with known liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nathanson RetractorLiver will be retracted with Nathanson retractor | Device | Nathanson Retractor |
| Reveel RetractorLiver will be retracted with Reveel retractor | Device | Reveel Retractor |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah Sisik principal investigator
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nathanson Retractor and Reveel Retractor in people with Obesity, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Sisik (00905062623325, abdullahsisik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in physiological parameters of liver due to trauma of retractors (time frame: within the first 2 days of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.