Liver DamageRETRACTORNCT03795844
COMPARISON OF LIVER RETRACTOR FOR INTRATOPERATIVE LIVER DAMAGE
A study testing liver retraction Nathanson retractor, liver retraction snake retractor and liver retraction fan retractor in people with Liver Damage, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries, the liver masses are also found to be significantly larger due to the high Body Mass Index scores. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Damage
- What is being tested?
- liver retraction Nathanson retractor, liver retraction snake retractor and liver retraction fan retractor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy
Who cannot join
- The patients with liver failure
- The patients with impaired preoperative liver function tests
- The patients who have been diagnosed with any liver disease
- The patients with bleeding disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734
About this study
Official title: COMPARISON OF LIVER RETRACTOR USED IN LAPAROSCOPIC SLEEVE GASTRECTOMY BY INTRAOPERATIVE LIVER DAMAGE
The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries, the liver masses are also found to be significantly larger due to the high Body Mass Index scores. It is known that the application of a diet called liver shrinkage protein diet which is applied preoperatively is a method that contributes to the comfort of the surgeon during surgery by reducing the size of the liver. The large size of the liver narrows the field of view of the surgeon in operation and decreases the comfort of surgery. One of the most important points that the surgeon must solve during surgery is the exclusion of the left lobe of the liver. The most commonly used types of liver retractors today; Nathanson retractor, Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other retractors. Some of these retractors require an additional incision under xiphoid, which may lead to an injury risk. The installation of these retractors also increases the operation time and requires additional time. Numerous studies have shown that retractors, which are used to rule out liver left lobe during surgery, cause liver damage. However, in order to reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is mandatory. Therefore, it is necessary to determine and use the retractor type which causes the least damage between the liver retractors. In our study, it was aimed to reveal three types of liver retractors in our hospital in different cases and to reveal the type of trocar that causes the least amount of liver damage.
Read the detailed description
During laparoscopic upper abdominal surgery, the operative view is usually blocked by the left lobe of the liver. An effective liver retraction is important for good vision and safety during operation. In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined with postoperative first day abdominal abdomen magnetic resonance imaging and the liver injury will be evaluated by the radiologist. Patients will not know which liver excision method is used during surgery. The radiologist who will perform damage assessment on imaging will not know which type of liver dislocation is used. Therefore, the study will be planned as double blind. The liver excision method will be applied sequentially. Randomization will be done in this way.
- Conditions
- Liver Damage
- Being tested
- liver retraction Nathanson retractor, liver retraction snake retractor, liver retraction fan retractor, liver retraction laparoscopic grasper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver retraction Nathanson retractorProcedure or surgery
Also called nathanson retractor
liver retractor will be used for the retraction of left lobe of liver
liver retraction snake retractorProcedure or surgery
liver retractor will be used for the retraction of left lobe of liver
liver retraction fan retractorProcedure or surgery
liver retractor will be used for the retraction of left lobe of liver
liver retraction laparoscopic grasperProcedure or surgery
laparoscopic grasper without any special tools
| Study group | Role | What they receive |
|---|---|---|
| Nathanson retractor | Active comparator | Liver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. Receives: Procedure: liver retraction Nathanson retractor |
| snake retractor | Active comparator | Liver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved. Receives: Procedure: liver retraction snake retractor |
| fan retractor | Active comparator | Liver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus Receives: Procedure: liver retraction fan retractor |
| CONTROL GROUP | Active comparator | Liver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools Receives: Procedure: liver retraction laparoscopic grasper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.
measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Nov 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DamageStudies 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
- Crossover
- Model description
- In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795844
- Sponsor's protocol ID
- ANIL ERGIN.......
- Acronym
- RETRACTOR
- Status last verified
- Mar 2021
- First submitted
- 2 Jan 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF LIVER RETRACTOR USED IN LAPAROSCOPIC SLEEVE GASTRECTOMY BY INTRAOPERATIVE LIVER DAMAGE
- ClinicalTrials.gov ID
- NCT03795844
- Acronym / sponsor ID
- RETRACTOR / ANIL ERGIN.......
- Conditions
- Liver Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 8 Jan 2019 (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.
The frequency of laparoscopic bariatric surgery is increasing day by day. In these surgeries, the liver masses are also found to be significantly larger due to the high Body Mass Index scores. It is known that the application of a diet called liver shrinkage protein diet which is applied preoperatively is a method that contributes to the comfort of the surgeon during surgery by reducing the size of the liver. The large size of the liver narrows the field of view of the surgeon in operation and decreases the comfort of surgery. One of the most important points that the surgeon must solve during surgery is the exclusion of the left lobe of the liver. The most commonly used types of liver retractors today; Nathanson retractor, Snowden-Window retractor, Snake retractor, Fan retractor, LIvac retractor and many other retractors. Some of these retractors require an additional incision under xiphoid, which may lead to an injury risk. The installation of these retractors also increases the operation time and requires additional time. Numerous studies have shown that retractors, which are used to rule out liver left lobe during surgery, cause liver damage. However, in order to reveal His angle in the esophageal-gastric composition, hepatic left lobe exclusion is mandatory. Therefore, it is necessary to determine and use the retractor type which causes the least damage between the liver retractors. In our study, it was aimed to reveal three types of liver retractors in our hospital in different cases and to reveal the type of trocar that causes the least amount of liver damage.
Detailed description
During laparoscopic upper abdominal surgery, the operative view is usually blocked by the left lobe of the liver. An effective liver retraction is important for good vision and safety during operation. In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools. In these patients, aspartate aminotransferase, alanine aminotransferase and Bilirubin levels will be examined on the postoperative 1st, 2nd and 3rd days and the patients will be examined with postoperative first day abdominal abdomen magnetic resonance imaging and the liver injury will be evaluated by the radiologist. Patients will not know which liver excision method is used during surgery. The radiologist who will perform damage assessment on imaging will not know which type of liver dislocation is used. Therefore, the study will be planned as double blind. The liver excision method will be applied sequentially. Randomization will be done in this way.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In this study, 120 patients who are over 18 years old with laparoscopic sleeve gastrectomy will be included. 4 groups will be formed and each group will be planned to include 30 patients. In group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. In the second group, a snake retractor with a 5 mm incision under the xiphoid will be used. In the 3rd group, liver retraction will be provided by using a 5 mm trocar from the intersection of the right midclavicular line. In the control group, liver retraction through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools.
| Arm | Type | Receives |
|---|---|---|
| Nathanson retractor | Active comparator | Procedure: liver retraction Nathanson retractorLiver retraction in group 1, a 5 mm incision was made under xiphoid during the operation, and Nathanson retractor was placed and liver left lobe retraction would be achieved. |
| snake retractor | Active comparator | Procedure: liver retraction snake retractorLiver retraction in group 2 ; 5 mm incision under the xiphoid will be used. Snake retractor was placed and liver left lobe retraction would be achieved. |
| fan retractor | Active comparator | Procedure: liver retraction fan retractorLiver retraction in group 3 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus |
| CONTROL GROUP | Active comparator | Procedure: liver retraction laparoscopic grasperLiver retraction in group 4 ; through a 5 mm trocar entrained from the intersection of the right midclavicular line and a 4 cm superior umbilicus will be provided with the aid of laparoscopic grasper without any special tools |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients older than 18 years planned for Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (4 listed)
- The patients with liver failure
- The patients with impaired preoperative liver function tests
- The patients who have been diagnosed with any liver disease
- The patients with bleeding disorders
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 |
|---|---|---|
| liver retraction Nathanson retractorAlso: nathanson retractorliver retractor will be used for the retraction of left lobe of liver | Procedure or surgery | Nathanson retractor |
| liver retraction snake retractorliver retractor will be used for the retraction of left lobe of liver | Procedure or surgery | snake retractor |
| liver retraction fan retractorliver retractor will be used for the retraction of left lobe of liver | Procedure or surgery | fan retractor |
| liver retraction laparoscopic grasperlaparoscopic grasper without any special tools | Procedure or surgery | CONTROL GROUP |
Primary outcome
Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels.
Time frame: 72 hours
measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels will be measured preoperatively and postoperative 0 , 1 , 2 , 3 days and record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver retraction Nathanson retractor, liver retraction snake retractor and liver retraction fan retractor in people with Liver Damage, run by Fatih Sultan Mehmet Training 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 4 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: finished, as of the sponsor's last update on 23 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver damage of liver retractors by measurement of AST(Aspartate Aminotransferase), ALT (alanine aminotransferase) , GGT (Gamma-Glutamyl Transferase) , Bilirubin (Total , direct , indirect ) levels. (time frame: 72 hours). 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 2021.