Morbid ObesityNCT06284356
Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy
An observational study of Morbid Obesity and Laparoscopic Sleeve Gastrectomy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Post Operative Complicaiton
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 May 2023
- How long will I take part?
- 4 Days
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Morbid Obesity cases preparing for LSG * Patients with a body mass index (BMI) value ≥ 40 kg/m2 and no known comorbidities * Patients with a BMI value ≥ 35 kg/m2 and additional comorbid diseases (such as Diabetes, Hypertension, Asthma, and Chronic Obstructive Pulmonary Disease)
Who may be able to join
- Completely normal, healthy individuals with no additional diseases and BMI values of 19-24 kg/m2 for the control group
- Older than 18 years who will undergo Laparoscopic Sleeve Gastrectomy
- Patients with a body mass index (BMI) value ≥ 40 kg/m2 and no known comorbidities
- Patients with a BMI value ≥ 35 kg/m2 and additional comorbid diseases (such as Diabetes, Hypertension, Asthma, and Chronic Obstructive Pulmonary Disease)
Who cannot join
- Individuals under 18 years of age and morbid obesity patients
- Patients who indicate elective surgery due to morbid obesity and who are planning for non-LSG morbid obesity surgery
- Patients who do not want to participate in the study
- Patients with additional diseases such as concurrent malignancy or rheumatological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pan Immune Inflammation Value for Determining Perioperative Complications of Laparoscopic Sleeve Gastrectomy: A Prospective Cohort Study
Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).
While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.
Read more
Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.
In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG.
Read the detailed description
Patients who will undergo LSG due to morbid obesity will be included in the study. Patients who are completely healthy, not morbidly obese, and have no additional disease will be taken as the control group. Reference range values will be obtained by taking a complete blood count from the control group once. From patients who will undergo LSG, routine pre-operative complete blood count values, and postoperative 24th-hour complete blood count values will be taken. PLR, NLR, and PIV will be calculated manually from these complete blood count samples and the change in these parameters will be evaluated between patients who develop complications and those who do not.
In descriptive statistics, categorical data will be given as number (n) and percentage (%). Numerical data will be given as mean ± standard deviation (SD) (minimum-maximum data) or median (25% - 75% values) depending on their compliance with normal distribution. The Kolmogorov-Simirnov test will be used to determine the distribution of normality. A p-value <0.05 is accepted as statistically significant.
- Being tested
- Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic Sleeve Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients without complications after LSG | Not described Receives: Procedure: Laparoscopic Sleeve Gastrectomy | |
| Patients with complications after LSG | Not described Receives: Procedure: Laparoscopic Sleeve Gastrectomy | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication prediction after LSG with complete blood cell parameters
Blood sample changes after LSG with complete blood cell parameters
Measured: 2022-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Elazig Special Eastern Anatolian Hospital
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284356
- Sponsor's protocol ID
- IRB Session 2022/14 Protocol 6
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kirkil C, Aygen E, Korkmaz MF, Bozan MB. QUALITY OF LIFE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY USING BAROS SYSTEM. Arq Bras Cir Dig. 2018 Aug 16;31(3):e1385. doi: 10.1590/0102-672020180001e1385.
PubMed 30133677Bozan MB, Kutluer N, Aksu A, Bozan AA, Kanat BH, Boyuk A. IS BODY MASS INDEX AND OBESITY SURGERY MORTALITY SCORE IMPORTANT IN PERIOPERATIVE COMPLICATIONS OF LAPAROSCOPIC SLEEVE GASTRECTOMY BEFORE DISCHARGE? Arq Bras Cir Dig. 2021 Oct 15;34(2):e1602. doi: 10.1590/0102-672020210002e1602. eCollection 2021.
PubMed 34669891Bozan MB. Gall Bladder Stone Formation in the Postoperative First Year After Sleeve Gastrectomy. Laparosc Endosc Surg Sci. 2020;27(1):25-9
Dogan F, Dincer M. Mini-gastric Bypass Complications and the Value of the Preoperative Neutrophil to Lymphocyte Ratio in Early Prediction of Complications. J Coll Physicians Surg Pak. 2021 Jan;31(1):70-73. doi: 10.29271/jcpsp.2021.01.70.
PubMed 33546537Ortiz-Lopez D, Acosta-Merida MA, Casimiro-Perez JA, Silvestre-Rodriguez J, Marchena-Gomez J. First day postoperative values of the neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and C-reactive protein as complication predictors following gastric oncologic surgery. Rev Gastroenterol Mex (Engl Ed). 2022 Apr-Jun;87(2):142-148. doi: 10.1016/j.rgmxen.2021.11.003. Epub 2021 Nov 15.
PubMed 34794921Gambichler T, Said S, Abu Rached N, Scheel CH, Susok L, Stranzenbach R, Becker JC. Pan-immune-inflammation value independently predicts disease recurrence in patients with Merkel cell carcinoma. J Cancer Res Clin Oncol. 2022 Nov;148(11):3183-3189. doi: 10.1007/s00432-022-03929-y. Epub 2022 Jan 31.
PubMed 35098389Sato S, Shimizu T, Ishizuka M, Suda K, Shibuya N, Hachiya H, Iso Y, Takagi K, Aoki T, Kubota K. The preoperative pan-immune-inflammation value is a novel prognostic predictor for with stage I-III colorectal cancer patients undergoing surgery. Surg Today. 2022 Aug;52(8):1160-1169. doi: 10.1007/s00595-021-02448-6. Epub 2022 Jan 11.
PubMed 35015151
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan Immune Inflammation Value for Determining Perioperative Complications of Laparoscopic Sleeve Gastrectomy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06284356
- Acronym / sponsor ID
- IRB Session 2022/14 Protocol 6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Elazig Special Eastern Anatolian Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Feb 2024 (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.
Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).
While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.
Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.
In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG.
Detailed description
Patients who will undergo LSG due to morbid obesity will be included in the study. Patients who are completely healthy, not morbidly obese, and have no additional disease will be taken as the control group. Reference range values will be obtained by taking a complete blood count from the control group once. From patients who will undergo LSG, routine pre-operative complete blood count values, and postoperative 24th-hour complete blood count values will be taken. PLR, NLR, and PIV will be calculated manually from these complete blood count samples and the change in these parameters will be evaluated between patients who develop complications and those who do not.
In descriptive statistics, categorical data will be given as number (n) and percentage (%). Numerical data will be given as mean ± standard deviation (SD) (minimum-maximum data) or median (25% - 75% values) depending on their compliance with normal distribution. The Kolmogorov-Simirnov test will be used to determine the distribution of normality. A p-value <0.05 is accepted as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients without complications after LSG | – | Procedure: Laparoscopic Sleeve Gastrectomy |
| Patients with complications after LSG | – | Procedure: Laparoscopic Sleeve Gastrectomy |
| Control Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid Obesity cases preparing for LSG * Patients with a body mass index (BMI) value ≥ 40 kg/m2 and no known comorbidities * Patients with a BMI value ≥ 35 kg/m2 and additional comorbid diseases (such as Diabetes, Hypertension, Asthma, and Chronic Obstructive Pulmonary Disease)
Key inclusion criteria (4 listed)
- Completely normal, healthy individuals with no additional diseases and BMI values of 19-24 kg/m2 for the control group
- Older than 18 years who will undergo Laparoscopic Sleeve Gastrectomy
- Patients with a body mass index (BMI) value ≥ 40 kg/m2 and no known comorbidities
- Patients with a BMI value ≥ 35 kg/m2 and additional comorbid diseases (such as Diabetes, Hypertension, Asthma, and Chronic Obstructive Pulmonary Disease)
Key exclusion criteria (4 listed)
- Individuals under 18 years of age and morbid obesity patients
- Patients who indicate elective surgery due to morbid obesity and who are planning for non-LSG morbid obesity surgery
- Patients who do not want to participate in the study
- Patients with additional diseases such as concurrent malignancy or rheumatological 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 |
|---|---|---|
| Laparoscopic Sleeve GastrectomyLaparoscopic Sleeve Gastrectomy | Procedure or surgery | Patients with complications after LSG, Patients without complications after LSG |
Primary outcome
Complication prediction after LSG with complete blood cell parameters
Time frame: 2022-2023
Blood sample changes after LSG with complete blood cell parameters
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 1 Mar 2024.
- Background: PubMed 30133677Kirkil C, Aygen E, Korkmaz MF, Bozan MB. QUALITY OF LIFE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY USING BAROS SYSTEM. Arq Bras Cir Dig. 2018 Aug 16;31(3):e1385. doi: 10.1590/0102-672020180001e1385.
- Background: PubMed 34669891Bozan MB, Kutluer N, Aksu A, Bozan AA, Kanat BH, Boyuk A. IS BODY MASS INDEX AND OBESITY SURGERY MORTALITY SCORE IMPORTANT IN PERIOPERATIVE COMPLICATIONS OF LAPAROSCOPIC SLEEVE GASTRECTOMY BEFORE DISCHARGE? Arq Bras Cir Dig. 2021 Oct 15;34(2):e1602. doi: 10.1590/0102-672020210002e1602. eCollection 2021.
- BackgroundBozan MB. Gall Bladder Stone Formation in the Postoperative First Year After Sleeve Gastrectomy. Laparosc Endosc Surg Sci. 2020;27(1):25-9
- Background: PubMed 33546537Dogan F, Dincer M. Mini-gastric Bypass Complications and the Value of the Preoperative Neutrophil to Lymphocyte Ratio in Early Prediction of Complications. J Coll Physicians Surg Pak. 2021 Jan;31(1):70-73. doi: 10.29271/jcpsp.2021.01.70.
- Background: PubMed 34794921Ortiz-Lopez D, Acosta-Merida MA, Casimiro-Perez JA, Silvestre-Rodriguez J, Marchena-Gomez J. First day postoperative values of the neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and C-reactive protein as complication predictors following gastric oncologic surgery. Rev Gastroenterol Mex (Engl Ed). 2022 Apr-Jun;87(2):142-148. doi: 10.1016/j.rgmxen.2021.11.003. Epub 2021 Nov 15.
- Background: PubMed 35098389Gambichler T, Said S, Abu Rached N, Scheel CH, Susok L, Stranzenbach R, Becker JC. Pan-immune-inflammation value independently predicts disease recurrence in patients with Merkel cell carcinoma. J Cancer Res Clin Oncol. 2022 Nov;148(11):3183-3189. doi: 10.1007/s00432-022-03929-y. Epub 2022 Jan 31.
- Background: PubMed 35015151Sato S, Shimizu T, Ishizuka M, Suda K, Shibuya N, Hachiya H, Iso Y, Takagi K, Aoki T, Kubota K. The preoperative pan-immune-inflammation value is a novel prognostic predictor for with stage I-III colorectal cancer patients undergoing surgery. Surg Today. 2022 Aug;52(8):1160-1169. doi: 10.1007/s00595-021-02448-6. Epub 2022 Jan 11.
- 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.
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?
An observational study of Morbid Obesity and Laparoscopic Sleeve Gastrectomy, run by Kahramanmaras Sutcu Imam University 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 4 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 1 Mar 2024. 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?
Complication prediction after LSG with complete blood cell parameters (time frame: 2022-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284356, which also lists 7 linked publications.
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 1 Mar 2024.