Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery
NCT ID: NCT06263101
Last Updated: 2024-12-27
Study Results
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Basic Information
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COMPLETED
86 participants
OBSERVATIONAL
2024-02-21
2024-12-12
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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 \[ADA\]).
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)
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)
Interventions
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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 \[ADA\]).
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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Chaoyang Hospital of China Medical University
OTHER_GOV
Responsible Party
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Locations
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Chaoyang Central Hospital of China Medical University
Chaoyang, Liaoning, China
Countries
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References
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Chapman SJ, Pericleous A, Downey C, Jayne DG. Postoperative ileus following major colorectal surgery. Br J Surg. 2018 Jun;105(7):797-810. doi: 10.1002/bjs.10781. Epub 2018 Feb 22.
Scarborough JE, Schumacher J, Kent KC, Heise CP, Greenberg CC. Associations of Specific Postoperative Complications With Outcomes After Elective Colon Resection: A Procedure-Targeted Approach Toward Surgical Quality Improvement. JAMA Surg. 2017 Feb 15;152(2):e164681. doi: 10.1001/jamasurg.2016.4681. Epub 2017 Feb 15.
Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
Hedrick TL, McEvoy MD, Mythen MMG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery. Anesth Analg. 2018 Jun;126(6):1896-1907. doi: 10.1213/ANE.0000000000002742.
Wehner S, Behrendt FF, Lyutenski BN, Lysson M, Bauer AJ, Hirner A, Kalff JC. Inhibition of macrophage function prevents intestinal inflammation and postoperative ileus in rodents. Gut. 2007 Feb;56(2):176-85. doi: 10.1136/gut.2005.089615. Epub 2006 Jun 29.
Bauer AJ. Mentation on the immunological modulation of gastrointestinal motility. Neurogastroenterol Motil. 2008 May;20 Suppl 1:81-90. doi: 10.1111/j.1365-2982.2008.01105.x.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ChaoyangHospital
Identifier Type: -
Identifier Source: org_study_id