Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy

NCT06284356 | Completed

• 1 other identifier: IRB Session 2022/14 Protocol 6
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity; Laparoscopic Sleeve Gastrectomy; Post Operative Complicaiton

Outcome Measures

Primary Outcomes (1)

• Complication prediction after LSG with complete blood cell parameters

  Blood sample changes after LSG with complete blood cell parameters

  2022-2023

Study Arms (3)

Patients without complications after LSG

Procedure: Laparoscopic Sleeve Gastrectomy

Patients with complications after LSG

Procedure: Laparoscopic Sleeve Gastrectomy

Control Group

Interventions

Laparoscopic Sleeve Gastrectomy PROCEDURE

Laparoscopic Sleeve Gastrectomy

Patients with complications after LSG; Patients without complications after LSG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead
• Elazig Special Eastern Anatolian Hospital: collaborator

Study Sites (1)

Kahramanmaras SIU

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 30133677 BACKGROUND

• 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.

  PMID: 34669891 BACKGROUND

• Bozan MB. Gall Bladder Stone Formation in the Postoperative First Year After Sleeve Gastrectomy. Laparosc Endosc Surg Sci. 2020;27(1):25-9

  BACKGROUND

• 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.

  PMID: 33546537 BACKGROUND

• 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.

  PMID: 34794921 BACKGROUND

• 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.

  PMID: 35098389 BACKGROUND

• 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.

  PMID: 35015151 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 28, 2024
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

TU (1)