Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorect… (NCT06263101) | Clinical Trial Compass
CompletedNot Applicable
Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery
China86 participantsStarted 2024-02-21
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of drainage fluid LDH and neutrophil to lymphocyte ratio (NLR) on postoperative day 1
Timeframe: Postoperative day 1
Trial details
NCT IDNCT06263101
SponsorChaoyang Hospital of China Medical University