An interventional study of Perioperative Biomarker-Guided Monitoring in Colorectal (Colon or Rectal) Cancer and STOMACH NEOPLASM, sponsored by Bucharest Emergency Hospital. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Bucharest Emergency Hospital · Not applicable, Interventional, and Supportive care
This study aims to evaluate whether monitoring perioperative inflammatory and metabolic biomarkers can help identify postoperative complications early in adult patients undergoing colorectal or gastric cancer surgery.
The study is a randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania. Participants are assigned to either an intervention group receiving enhanced recovery care (ERAS) combined with perioperative biomarker monitoring or a control group receiving standard postoperative care.
The biomarkers of interest include procalcitonin, lactate, and blood glucose. The study will examine their relationship with postoperative complications, particularly infections and anastomotic leakage.
Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
The findings may help improve postoperative monitoring and support earlier recognition of complications in patients undergoing cancer surgery.
Study Design and Objectives
This study is a prospective, single-center, randomized controlled trial conducted at Bucharest Emergency Clinical Hospital, Romania, involving adult patients undergoing surgery for colorectal or gastric cancer.
The primary objective is to investigate whether perioperative monitoring of inflammatory and metabolic biomarkers, integrated into postoperative care, can facilitate early identification of postoperative complications within 30 days after surgery.
Randomization and Study Groups
Eligible participants are randomly assigned to one of two study groups using stratified block randomization. Allocation is performed using sealed envelopes prepared independently of the investigator.
The intervention group receives perioperative care incorporating Enhanced Recovery After Surgery (ERAS) principles and structured biomarker monitoring.
The control group receives standard perioperative care without protocol-mandated postoperative biomarker monitoring.
Biomarker Assessment
The biomarkers evaluated include procalcitonin (PCT), blood lactate, and blood glucose.
Preoperative assessment includes lactate, blood glucose, and serum electrolytes.
Postoperative biomarker monitoring in the intervention group includes lactate and procalcitonin approximately 12 hours after surgery, followed by additional procalcitonin measurements on postoperative days 3, 5, and 7.
Procalcitonin is assessed using a point-of-care semi-quantitative method.
Clinical Outcomes
Patients are followed for 30 days after surgery to assess postoperative complications, including surgical site infections, anastomotic leakage, and other infectious or non-infectious complications.
Additional outcomes include postoperative mortality, hospital length of stay, and hospital readmissions.
Clinical and laboratory findings will be analyzed to explore associations between perioperative biomarker patterns and postoperative outcomes and to evaluate the potential clinical usefulness of biomarker-guided postoperative monitoring.
Ethical Considerations
The study was approved by the hospital's Ethics Committee (Approval No. 46148, dated October 27, 2025). Written informed consent is obtained from all participants before enrollment.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 320 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
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Exclusion Criteria:
Participants assigned to the intervention group will receive an Enhanced Recovery After Surgery (ERAS)-based perioperative care protocol combined with serial biomarker monitoring. Biomarkers include blood lactate, procalcitonin (PCT), and blood glucose. Postoperative lactate and PCT are assessed at 12 hours, with additional PCT measurements on postoperative days 3, 5, and 7. Biomarker results are evaluated alongside clinical findings to support early identification of postoperative complications, particularly infections and anastomotic leakage. Participants are followed for 30 days after surgery.
Diagnostic Test: Perioperative Biomarker-Guided Monitoring
Participants assigned to the control group will receive standard perioperative care according to the hospital's routine clinical protocols for colorectal or gastric cancer surgery. Postoperative monitoring will be based on clinical assessment and routine laboratory investigations. No additional protocol-mandated serial procalcitonin or lactate measurements will be performed as part of the study intervention. Any laboratory investigations or treatments considered clinically necessary will remain available at the discretion of the treating physician. Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
Participants allocated to the experimental group will undergo perioperative biomarker monitoring integrated into an Enhanced Recovery After Surgery (ERAS) protocol. Biomarker assessments will include preoperative blood lactate and glucose measurements, postoperative lactate and procalcitonin measurements at 12 hours, and additional procalcitonin assessments on postoperative days 3, 5, and 7. Biomarker results will be evaluated alongside clinical findings to support postoperative monitoring and early recognition of complications, particularly infections and anastomotic leakage. Participants will be followed for 30 days after surgery to assess postoperative complications, hospital length of stay, readmissions, and mortality.
Predictive Performance of Perioperative Biomarkers for Postoperative Complications
The predictive performance of perioperative procalcitonin, lactate, and blood glucose levels for postoperative complications will be assessed using receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC). Postoperative complications, including infections and anastomotic leakage, will be assessed within 30 days after surgery.
Time frame: Up to 30 days after surgery.
Incidence of Postoperative Infections
Proportion of participants developing at least one clinically diagnosed postoperative infection, including surgical site infections and intra-abdominal infections, within 30 days after colorectal or gastric cancer surgery. The incidence will be compared between the intervention and control groups.
Time frame: Up to 30 days after surgery
Incidence of Anastomotic Leakage
Proportion of participants developing clinically or radiologically confirmed anastomotic leakage following colorectal or gastric cancer surgery. The incidence of anastomotic leakage will be compared between the intervention and control groups.
Time frame: Up to 30 days after surgery
Length of Hospital Stay
Duration of postoperative hospitalization, measured in days from the date of surgery to hospital discharge. The length of hospital stay will be compared between the intervention and control groups.
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days
30-Day All-Cause Mortality
Proportion of participants who die from any cause within 30 days after surgery. Mortality rates will be compared between the intervention and control groups.
Time frame: Up to 30 days after surgery
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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