Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Morbid Obesity Body Weight Laparoscopic Sleeve Gastrectomy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Post Operative Complicaiton Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kahramanmaras SIU

Kahramanmaraş, 46000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Laparoscopic Sleeve Gastrectomy

Primary outcomes

Complication prediction after LSG with complete blood cell parameters

Time frame: 2022-2023

Blood sample changes after LSG with complete blood cell parameters

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Collaborators

Elazig Special Eastern Anatolian Hospital

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Feb 28, 2024
Registry last updated: Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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