Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:

Pan Immune Inflammation Value for Determining Perioperative Complications of Laparoscopic Sleeve Gastrectomy: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06284356
• Other study ID #: IRB Session 2022/14 Protocol 6
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Inflammation
• Laparoscopic Sleeve Gastrectomy
• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy

Locations

Country	Name	City	State
Turkey	Kahramanmaras SIU	Kahramanmaras

Sponsors (2)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University	Elazig Special Eastern Anatolian Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Bozan 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. — View Citation

Bozan 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. — View Citation

Gambichler 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. — View Citation

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. — View Citation

Ortiz-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. — View Citation

Sato 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication prediction after LSG with complete blood cell parameters	Blood sample changes after LSG with complete blood cell parameters	2022-2023