Role of Serial C-reactive Protein Concentration Analysis With Computed Tomography in Limiting the… (NCT07722533) | Clinical Trial Compass
CompletedNot Applicable
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
Egypt60 participantsStarted 2022-12-15
Plain-language 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.
Who can participate
Age range
18 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:
* 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 imag…
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
Successful avoidance of a defunctioning ileostomy without clinically relevant anastomotic leakage
Timeframe: From the index operation through postoperative day 30.