Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery

December 21, 2024 updated by: Chaoyang Hospital of China Medical University

Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Colorectal Surgery. A Monocentric Prospective Observational Study

Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI) after colorectal surgery, is characterized by symptoms such as nausea, vomiting, abdominal distension, and delayed bowel movements. The incidence of this issue varies among medical institutions, impacting patient nutrition, prolonging hospital stays, and increasing healthcare costs.

The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD. Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery, emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function.

This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery. The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery (ERAS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative gastrointestinal dysfunction (POGD), often referred to as postoperative ileus (POI), is a common gastrointestinal issue that frequently occurs after colorectal surgery. It is characterized by symptoms such as nausea and vomiting, abdominal distension, and delayed defecation and evacuation. The incidence of POI is not clearly defined due to the varying definitions across healthcare institutions, but it is estimated to be approximately 10-30% and is one of the most common complications after colorectal surgery. The occurrence of POI increases the nutritional risk of patients (e.g., malnutrition, myasthenia gravis, malignant morbidity), prolongs the length of hospital stay, increases hospital costs, and significantly adds to the health economic burden.

In 2018, the American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement considered abandoning the traditional definition of POI and proposed a scoring system based on intake, sensation of nausea, vomiting, physical examination, and duration of symptoms (I-FEED). They also introduced a definition of postoperative gastrointestinal dysfunction (POGD) based on scores classifying postoperative gastrointestinal function as normal (0-2), postoperative gastrointestinal intolerance (POGI) (3-5), and postoperative gastrointestinal dysfunction (POGD) (>6).

The complex pathogenesis of POGD involves a brief neurogenic phase (within 3 hours) and a more prolonged inflammatory phase (beginning at 3-4 hours and lasting for days). The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer. Subsequently, it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells, which contributes to the development and exacerbation of POGD.

Levels of inflammatory cells and factors in the peritoneal fluid are changed following abdominal surgery in both rodents and humans. Many previous studies have confirmed that the use of drainage fluids also reduces the incidence of elevated inflammatory markers, such as CRP, in the presence of unrelated inflammatory stimuli, such as concurrent infections and systemic diseases. For instance, in other diseases like meningitis, blood IL-6 is less specific than IL-6 in the drainage fluid. In addition, abdominal drainage fluid is more effective and efficient than routinely collected blood for detecting anastomotic leakage (AL) following colorectal cancer surgery. However, fewer studies have been conducted to predict the recovery of postoperative gastrointestinal function by analyzing drainage fluid. We believe that analyzing postoperative gastrointestinal drainage fluid is of greater clinical importance in predicting postoperative gastrointestinal function.

In our study, we collected abdominal drainage fluid near the anastomosis on the first and third day after laparoscopic colorectal cancer surgery for biochemical and cytological tests. These tests included lactate dehydrogenase (LDH), adenosine deaminase (ADA) and albumin. We also performed conventional cytological tests for neutrophils, lymphocytes, monocytes, etc. In addition, we calculated inflammatory indices such as neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR) and prognostic nutrition index (PNI). We also collected peripheral blood for the same cytological indices and evaluated the outcome of the patients' gastrointestinal function recovery using the I-FEED score. In addition, we analyzed the correlation between the above indices and PODG, and combined the inflammation indices of peritoneal drainage and serum to predict the outcome of gastrointestinal function recovery after laparoscopic colorectal cancer surgery aiming to improve the accuracy and effectiveness of prediction and accelerate patient recovery.

Study Type

Observational

Enrollment (Actual)

86

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

  • China
    • Liaoning
      • Chaoyang, Liaoning, China
        • Chaoyang Central Hospital of China Medical University

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

Non-Probability Sample

Study Population

Patients aged 18-80 with preoperative colorectal cancer diagnosis through colonoscopy biopsy underwent laparoscopic radical resection, excluding prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated by signing informed consent.

Description

Inclusion Criteria:

  • Preoperative diagnosis of colorectal cancer through colonoscopy biopsy.
  • Patients aged 18-80 years.
  • Underwent laparoscopic radical resection for colorectal cancer with confirmed postoperative pathology.
  • No prior radiotherapy, chemotherapy, or immunotherapy before surgery.
  • Voluntary participation in the study and signing of a written informed consent form.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Severe liver dysfunction (Child-Pugh class B or above); severe renal dysfunction (serum creatinine level greater than 177).
  • Patients with severe heart failure, chronic obstructive pulmonary disease, and other underlying diseases.
  • Patients with pre-existing severe infections (developing sepsis or not improving after antibiotic treatment) before surgery.
  • Patients with postoperative fistulas or those requiring a two-stage anastomosis.
  • Intraoperative and postoperative intraperitoneal chemotherapy.
  • Blood disorders (leukemia, lymphoma, aplastic anemia, etc.).
  • Patient or family member withdraws midway.
  • Those with serious post-operative infections (e.g., incisional, lung, and urinary tract infections)
  • Intraoperative conversion to open laparotomy.

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
Biomarker-group
We considered for the study all patients diagnosed with colorectal cancer through preoperative colonoscopy, aged 18-80, underwent laparoscopic radical resection with confirmed pathology, without prior radiotherapy, chemotherapy, or immunotherapy, and voluntarily participated in and signed informed consent for the study, collected indicators of inflammation in the peripheral blood and post-operative drainage fluid of enrolled patients on post-operative days 1 and 3.
Other: Biochemical testing of abdominal drainage fluid
Drainage fluid was collected from patients on the first and third postoperative days to test the levels of three biochemical tests (albumin, lactate dehydrogenase [LDH], adenosine deaminase [ADA]).
Other: Cytological examination of abdominal drainage fluid
Cytological examination of abdominal drainage fluid on the first postoperative day and the third postoperative day, calculation of neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI)
Other: Peripheral blood cytology tests
Peripheral blood cytology tests on the first postoperative day and the third postoperative day, calculation of Neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet lymphocyte ratio (PLR), systemic immunoinflammatory index (SII)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1
Time Frame: Postoperative day 1
Our primary endpoint was to assess the role of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1.
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3
Time Frame: Postoperative day 3
Our Secondary endpoint was to assess the role of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3.
Postoperative day 3
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1.
Time Frame: Postoperative day 1
Our Secondary endpoint was to assess the role of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 1.
Postoperative day 1
Measurement of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3.
Time Frame: Postoperative day 3
Our Secondary endpoint was to assess the role of blood serum neutrophil-lymphocyte ratio (NLR), lymphocyte-monocyte ratio (LMR), platelet-lymphocyte ratio (PLR), systemic immune-inflammatory index (SII) on postoperative day 3.
Postoperative day 3
Measurement of drainage fluid albumin, adenosine deaminase (ADA), a d lymphocyte-monocyte ratio (LMR) on postoperative day 1
Time Frame: Postoperative day 1
Our Secondary endpoint was to assess the role of drainage fluid albumin, adenosine deaminase (ADA),and lymphocyte-monocyte ratio (LMR) on postoperative day 1.
Postoperative day 1
Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR) on postoperative day 3
Time Frame: Postoperative day 3
Our Secondary endpoint was to assess the role of drainage fluid albumin, adenosine deaminase (ADA),and lymphocyte-monocyte ratio (LMR) on postoperative day 3.
Postoperative day 3

Collaborators and Investigators

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

Sponsor

Chaoyang Hospital of China Medical University

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

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)

February 21, 2024

Primary Completion (Actual)

December 12, 2024

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ChaoyangHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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