Perioperative Blood Adiponectin Dynamics and Systemic Infflamatory Response After Major Colorectal Surgery

NCT06057207 | Completed

• 1 other identifier: ADIPOS study
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

Surgical stress after major abdominal surgery in perioperative period causes neuroendocrine, metabolic and imunologic changes in organism with production of proinfflamatory citokines and results with appearance of systemic infflammmatory response syndrome (SIRS). Dysregulated and overrated SIRS in early postoperative period can lead to complications with additional comorbidities, longer hospital stay and poorer outcome. A low grade chronic infflammatory state in obesity and hypoadiponectinemia can enable the cytokine storm and exaggerated /dysregulated SIRS in obese patients after surgery. Obesity according to this knowledge presents independent risk factor for developing more severe systemic infflamatory response syndrome in early postoperative period after major abdominal surgery. Also, chronic intestinal and gut infflamation is leading theory in oncogenesis of colorectal carcinoma according to recent findings. Many studies find low adiponectin levels in patients with colorectal carcinoma compared to healthy population. Obesity and colorectal cancer have infflamation and low adiponectin level as mutual factor which can be the important key in pathophysiology process of colorectal oncogenesis which are extremly complicated , multifactorial and intertwining. Hypothesis: Lower blood adiponectin levels are associated with higher systemic infflamatory response in patients after major abdominal surgery. Major aim of this study is to investigate correlation between perioperative blood levels of adiponectin and clinical signs of systemic infflamation and blood markers of systemic infflamation in patients after major colorectal surgery.

Conditions

Obesity, Abdominal; Surgery; Systemic Inflammatory Response Syndrome; Postoperative Complications; Colorectal Carcinoma (CRC); Adiponectin

Keywords

adiponectin; IL-6; obesity; surgery; systemic infflamatory response syndrome; colorectal carcinoma; final outcome

Outcome Measures

Primary Outcomes (1)

• Adiponectin

  Three measurements of adiponectin will be taken from blood samples of every patient preoperative, 24 and 72 hours postoperative

  Preoperative, 24 hours after surgery, 72 hours after surgery

Secondary Outcomes (1)

• IL-6

  Preoperative, 24 hours after surgery, 72 hours after surgery

Study Arms (1)

all patients presenting for elective open colorectal resection due to colorectal carcinoma

Diagnostic Test: serum levels of adiponectin; Diagnostic Test: IL-6; Other: Postoperative systemic infflamation; Other: Postoperative complications

Interventions

serum levels of adiponectin DIAGNOSTIC_TEST

adiponectin level will be measured on a day of surgery, 24 hours and 72 hours after surgery

all patients presenting for elective open colorectal resection due to colorectal carcinoma

IL-6 DIAGNOSTIC_TEST

IL-6 level will be measured on a day of surgery, 24 hours and 72 hours after surgery

all patients presenting for elective open colorectal resection due to colorectal carcinoma

Postoperative systemic infflamation OTHER

systemic infflamatory response syndrome (SIRS) will be estimated in firs 72 hours after surgery by clinical criteria: apperance of at least 2 from 4 major clinical signs of SIRS: heart rate\>90/min, body temperature \>38 C or \<36 C, WBC \>12 000 or \<4000, hyperventilation, CRP \>50mg/L, PCT \> 0.5 ug/L.

all patients presenting for elective open colorectal resection due to colorectal carcinoma

Postoperative complications OTHER

Complications in early postoperative period during hospitalisation will be including: surgical operation site related: anastomotic or laparotomic dehiscence, wound/local infection, postoperative bleeding, reoperation and nonsurgical site complications: sepsis, pneumonia, noncardiac respiratory failure, (need for noninvasive oxygen therapy), prolonged mechanical ventilation \>24 hours postoperative, reintubation, repeated mechanical ventilation atrial fibrillation, congestive heart failure, myocardial infarction, acute kidney injury/failure, postoperative delirium. Length of ICU and overall hospital stay with after discharge from hospital will be documented.

all patients presenting for elective open colorectal resection due to colorectal carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting for major (open) elective colorectal surgery of colorectal carcinoma

You may qualify if:

• Diagnose of colorectal cancer Age \>18 years Patient presenting for major (open) elective colorectal surgery according to carcinoma.
• Written informed consent.

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (2)

Osijek University Hospital

Osijek, Osijek, 31000, Croatia

Location

Sonja Škiljić

Osijek, Osijek, 31000, Croatia

Location

Related Publications (5)

• Florescu A, Branisteanu D, Bilha S, Scripcariu D, Florescu I, Scripcariu V, Dimofte G, Grigoras I. Leptin and adiponectin dynamics at patients with rectal neoplasm - Gender differences. PLoS One. 2019 Aug 19;14(8):e0212471. doi: 10.1371/journal.pone.0212471. eCollection 2019.

  PMID: 31425509 BACKGROUND

• Boersema GSA, Wu Z, Menon AG, Kleinrensink GJ, Jeekel J, Lange JF. Systemic Inflammatory Cytokines Predict the Infectious Complications but Not Prolonged Postoperative Ileus after Colorectal Surgery. Mediators Inflamm. 2018 Mar 6;2018:7141342. doi: 10.1155/2018/7141342. eCollection 2018.

  PMID: 29692682 BACKGROUND

• Barbic J, Ivic D, Alkhamis T, Drenjancevic D, Ivic J, Harsanji-Drenjancevic I, Turina I, Vcev A. Kinetics of changes in serum concentrations of procalcitonin, interleukin-6, and C- reactive protein after elective abdominal surgery. Can it be used to detect postoperative complications? Coll Antropol. 2013 Mar;37(1):195-201.

  PMID: 23697273 BACKGROUND

• Neskovic N, Mandic D, Marczi S, Skiljic S, Kristek G, Vinkovic H, Mraovic B, Debeljak Z, Kvolik S. Different Pharmacokinetics of Tramadol, O-Demethyltramadol and N-Demethyltramadol in Postoperative Surgical Patients From Those Observed in Medical Patients. Front Pharmacol. 2021 Apr 15;12:656748. doi: 10.3389/fphar.2021.656748. eCollection 2021.

  PMID: 33935773 BACKGROUND

• Wei Y, Zhu F, Gong J, Yang J, Zhang T, Gu L, Zhu W, Guo Z, Li Y, Li N, Li J. High Visceral to Subcutaneous Fat Ratio Is Associated with Increased Postoperative Inflammatory Response after Colorectal Resection in Inflammatory Bowel Disease. Gastroenterol Res Pract. 2018 Apr 3;2018:6270514. doi: 10.1155/2018/6270514. eCollection 2018.

  PMID: 29849595 BACKGROUND

Related Links

• Leptin and adiponectin dynamics at patients with rectal neoplasm - Gender differences.
• Systemic Inflammatory Cytokines Predict the Infectious Complications but Not Prolonged Postoperative Ileus after Colorectal Surgery.
• Kinetics of changes in serum concentrations of procalcitonin, interleukin-6, and C- reactive protein after elective abdominal surgery. Can it be used to detect postoperative complications?
• Different Pharmacokinetics of Tramadol, O-Demethyltramadol and N-Demethyltramadol in Postoperative Surgical Patients From Those Observed in Medical Patients.
• High Visceral to Subcutaneous Fat Ratio Is Associated with Increased Postoperative Inflammatory Response after Colorectal Resection in Inflammatory Bowel Disease

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples from every patient will be taken preoperatively, 24 hours and 72 hours postoperatively.

MeSH Terms

Conditions

Obesity, Abdominal; Systemic Inflammatory Response Syndrome; Postoperative Complications; Colorectal Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes; Shock; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Slavica Kvolik

  Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: July 27, 2023
• Primary Completion: May 1, 2025
• Study Completion: August 22, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CR (2)