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NCT07722533
Role of Serial C-reactive Protein Concentration Analysis With Computed Tomography in Limiting the Need for Protective Defunctioning Ileostomy After Laparoscopic Low Anterior Resection - A Prospective Study
Conditions: Rectal Cancer Patients, Anastomotic Leakage, Low Anterior Resection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Alexandria University
Location: Alexandria main university hospital Alexandria Please Select
Summary
Anastomotic leakage is a clinically important complication following laparoscopic low anterior resection. A protective defunctioning ileostomy may reduce the clinical consequences of leakage but is associated with stoma-related morbidity, dehydration, readmission and the need for a subsequent closure procedure.
This prospective study will evaluate the safety and clinical utility of a standardized postoperative surveillance pathway based on serial serum C-reactive protein measurements and selective computed tomography in patients undergoing laparoscopic low anterior resection in whom routine protective ileostomy is considered potentially avoidable.
Serum C-reactive protein will be measured at predefined postoperative time points. Contrast-enhanced computed tomography, with rectal contrast when clinically appropriate, will be performed when patients meet predefined biochemical or clinical criteria. The study will evaluate successful avoidance of a defunctioning ileostomy, clinically relevant anastomotic leakage, diagnostic performance of serial C-reactive protein, use of computed tomography, time to diagnosis, postoperative morbidity, reoperation, hospital stay and readmission.
Eligibility Criteria
Inclusion Criteria:
* Age 18 years or older.
* Elective laparoscopic low anterior resection.
* Primary colorectal or coloanal anastomosis.
* Diagnosis of \[rectal adenocarcinoma / rectal neoplasm / specified benign diseases\].
* Anastomosis located \[insert distance\] cm or less from the anal verge, if applicable.
* Participant considered suitable for omission of routine protective ileostomy according to predefined intraoperative criteria.
* Negative or adequately repaired intraoperative anastomotic leak test.
* Satisfactory anastomotic perfusion according to \[clinical assessment/indocyanine green fluorescence\].
* Ability to provide written informed consent.
* Agreement to complete postoperative follow-up.
Exclusion Criteria:
* Emergency surgery.
* Abdominoperineal resection or procedure without a colorectal/coloanal anastomosis.
* Planned permanent stoma.
* Pre-existing ileostomy or colostomy.
* Gross intraoperative contamination or generalized peritonitis.
* Positive anastomotic leak test that cannot be satisfactorily repaired.
* Unsatisfactory anastomotic perfusion.
* Major technical difficulty requiring protective diversion according to the protocol.
* Active systemic infection before surgery.
* Chronic inflammatory or autoimmune condition expected to substantially alter CRP concentrations.
* Current long-term systemic corticosteroid or significant immunosuppressive treatment
* Severe renal impairment preventing contrast-enhanced CT, when no suitable alternative imaging pathway is available.
* Known severe allergy to iodinated contrast without an appropriate alternative.
* Pregnancy.
* Inability to comply with postoperative surveillance or follow-up.
Source: ClinicalTrials.gov (NCT07722533). StuddyBuddy aggregates publicly available trial information.