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

August 23, 2025 updated by: Sonja Skiljic, Osijek University Hospital

Effects of Perioperative Circulating Adiponectin Levels on Postoperative Systemic Inflammatory Response in Patients Undergoing Major Colorectal Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal tumors are commonly presented for surgical resections. According to Global Cancer Statistics 2020: GLOBOCAN estimates colorectal carcinoma ranks third in terms of incidence, but second in terms of mortality for overall carcinomas worldwide. At the same time, obesity is a fast growing disease with of pandemic proportions with a current global prevalence of 39% according to the World Health Organisation (WHO). Many patients presented for major abdominal resections of colrectal carcinomas are obese. Obesity is chronic disease with complex pathophisiology. Adipose tissue besides being a storage site is responsible for secretion of various adipokines with imunometabolic role. Adipokines (also called adipocytokines) are cell-signaling molecules (cytokines) produced by the adipose tissue that play many functional roles in energy/metabolic status of the body, and inflammation. Among adipokines, adiponectin is predominantly antiinfflamatory adipokine which inhibits production of infflammatory citokines (IL-6) and is decreased in obesity. Adipocyte dysfunction in obesity with altered adipokines release results in chronic low-grade inflammatory state. Obesity is also well known risk factor for colorectal carcinoma in which oncogenesis adiponectin may be the important key according to recent findings.

Surgical stress after major colorectal 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 colorectal carcinoma associated with potential hypoadiponectinemia can enable the cytokine storm and exaggerated /dysregulated SIRS in these patients after surgery. Due to this knowledge, it is logical to presume that adiponectin levels in perioperative period are associated with the intensity of systemic infflamatory response after major colorectal surgery.

Hypothesis: Perioperative blood adiponectin levels are associated with higher intensity of systemic infflamatory response in patients after major colorectal surgery.

Aim of this study is to:

  1. Measure and investigate correlation between perioperative blood adiponectin levels and appearance and intensity of systemic infflamatory response in patients after major colorectal surgery.
  2. Investigate correlation between perioperative blood adiponectin levels, SIRS and postoperative complications, days of ICU and lenght of hospital stay in patients presenting for major colrectal surgery.

Research plan: After ethical approval and written informed consent, demographic, antropometric and comorbidities data will be taken from all patients included in study. BMI, waist circumference and ultrasound measurments of abdominal fat thickness ( superficial and visceral abdominal fat thickness) will be taken preoperatively. Blood collections for determining adiponectin levels, IL-6, Complete Blood Count with Differential Blood Count, lactats in arterial blood, C-reactive protein(CRP), procalcitonin(PCT), albumins (ALB), neutrophil/lymphocite ratio (NLR), platelet/lymphocyte ratio (PLR), CRP/ALB ratio, Systemic Immune-Inflammation Index (SII), Systemic inflammation response index (SIRI) will be taken before surgery (1), 24 hours after surgery (2) and 72 hours after surgery (3). All patients will bi given the same technique of balanced general endotracheal anesthesia with the same drugs and the same postoperative multimodal analgesia regimen. Appearance of SIRS in first 72 hours postoperative period will be detected and documented according to standardized major clinical SIRS criteria. Complications in early postoperative period during hospitalisation will be including: surgical operation site related according to standardized Clavien-Dindo classification: anastomotic dehiscence, wound/local infection, postoperative bleeding, reoperation and systemic complications: sepsis, pneumonia, noncardiac respiratory failure, (need for noninvasive oxygen therapy), prolonged mechanical ventilation >24 hours postoperative, reintubation, repeated mechanical ventilation, cardiovascular complications: atrial fibrillation, congestive heart failure, myocardial infarction, acute kidney injury/failure, postoperative delirium presence. After surgery, histological tumor grade, pathohistological tumor staging ( 8th edition of the American Joint Committee on Cancer (AJCC) staging) and tumor localisation ( colon/rectum) will be documented.

Length of ICU and overall hospital stay with outcome of surviving or death after discharge from hospital will be documented.

Significance/Expected scientific contribution: Understanding of the underlying pathophysiological mechanisms which contributes to the appearance and severity of SIRS with possible complications in early postoperative period is important for developing more predictive diagnostics and possible treatment options for improvements in outcome especially in major surgical procedures. The adipocytokines have important role in many aspects of inflammation and immunity. This study can help in better understanding the infflamatory role od adiponectin in pathophysiology of SIRS after major colorectal surgery.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Osijek
      • Osijek, Osijek, Croatia, 31000
        • Osijek University Hospital
      • Osijek, Osijek, Croatia, 31000
        • Sonja Škiljić

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Written informed consent.

Exclusion Criteria:

Age<18 years BMI<18.5kg/m2 Acute surgical conditions Established acute systemic/local infection Chronic/actual corticosteroid therapy Active immunomodulation therapy Allergie to used anestehetics/analgetics in study. Patient refusal Laparoscopic surgery Massive intraoperative surgical bleeding Preexisting concomitant second carcinoma other than colorectal origin Patients which does not fulfill inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all patients presenting for elective open colorectal resection due to colorectal carcinoma
Diagnostic test: serum levels of adiponectin
adiponectin level will be measured on a day of surgery, 24 hours and 72 hours after surgery
Diagnostic test: IL-6
IL-6 level will be measured on a day of surgery, 24 hours and 72 hours after surgery
Other: Postoperative systemic infflamation
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.
Other: Postoperative complications
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiponectin
Time Frame: Preoperative, 24 hours after surgery, 72 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6
Time Frame: Preoperative, 24 hours after surgery, 72 hours after surgery
Three measurements of IL-6 will be taken from blood samples of every patient preoperative, 24 and 72 hours postoperative
Preoperative, 24 hours after surgery, 72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osijek University Hospital

Investigators

  • Study Director: Slavica Kvolik, Department of Anaesthesiology, Resuscitation and ICU, Osijek University Hospital,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

August 22, 2025

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 23, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADIPOS study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After study completion, upon reasonable request, data may be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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