protocolSection identificationModule nctId: NCT06263101, orgStudyIdInfo id: ChaoyangHospital, briefTitle: Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chaoyang Hospital of China Medical University, class: OTHER_GOV, descriptionModule briefSummary: 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)., conditionsModule conditions: Postoperative Gastrointestinal Dysfunction (POGD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Biochemical testing of abdominal drainage fluid, interventions name: Cytological examination of abdominal drainage fluid, interventions name: Peripheral blood cytology tests, outcomesModule primaryOutcomes measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1, secondaryOutcomes measure: Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 3, secondaryOutcomes measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 1, secondaryOutcomes measure: Measurement of drainage fluid albumin, adenosine deaminase (ADA), lymphocyte-monocyte ratio (LMR), prognostic nutritional index (PNI) on postoperative day 3, secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chaoyang Central Hospital of China Medical University, status: RECRUITING, city: Chaoyang, state: Liaoning, country: China, contacts name: Xinao Fu, role: CONTACT, phone: +8618238692250, email: ailun10211@163.com, geoPoint lat: 41.57028, lon: 120.45861, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-08, uploadDate: 2024-02-12T01:53, filename: Prot_000.pdf, size: 182027, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-08, uploadDate: 2024-02-12T01:52, filename: SAP_001.pdf, size: 154895, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-08, uploadDate: 2024-02-12T01:37, filename: ICF_002.pdf, size: 277845, hasResults: False