Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery

NCT06263101 | Completed

• 1 other identifier: ChaoyangHospital
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Gastrointestinal Dysfunction (POGD)

Keywords

postoperative ileus; drainage fluid; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on 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 Outcomes (5)

• Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) 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

  Postoperative day 1

• Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR) 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.

  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.

  Postoperative day 3

Study Arms (1)

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; Other: Cytological examination of abdominal drainage fluid; Other: Peripheral blood cytology tests

Interventions

Biochemical testing of abdominal drainage fluid OTHER

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 \[ADA\]).

Biomarker-group

Cytological examination of abdominal drainage fluid OTHER

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)

Biomarker-group

Peripheral blood cytology tests OTHER

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)

Biomarker-group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chaoyang Hospital of China Medical University: lead

Study Sites (1)

Chaoyang Central Hospital of China Medical University

Chaoyang, Liaoning, China

Location

Related Publications (6)

• 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.

  PMID: 29469195 BACKGROUND

• 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.

  PMID: 27926773 BACKGROUND

• 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.

  PMID: 19610681 BACKGROUND

• 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.

  PMID: 29293183 BACKGROUND

• 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.

  PMID: 16809419 BACKGROUND

• 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.

  PMID: 18402645 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Preoperative and postoperative blood samples. Postoperative drain fluid samples.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 16, 2024
• Study Start: February 21, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-10

Locations

CN (1)