Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Col… (NCT07725692) | Clinical Trial Compass
CompletedNot Applicable
Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
Egypt3,200 participantsStarted 2016-05-01
Plain-language summary
Anastomotic leakage is a serious complication following colorectal cancer resection and may result in emergency reoperation, severe sepsis, death, loss of the colorectal anastomosis, and formation of a long-term or permanent intestinal stoma.
This multicentre observational cohort study will investigate patients who develop an anastomotic leak following colorectal cancer resection with primary anastomosis. The study will evaluate patient-related, tumour-related, operative, biochemical, radiological, leak-related, and treatment-related factors associated with three major outcomes: unplanned rescue surgery, 90-day mortality, and permanent stoma formation.
No treatment will be assigned by the investigators. Diagnosis and management of anastomotic leakage will be determined by the treating surgical teams according to their usual clinical practice. Participants will be followed for at least 12 months after the index colorectal resection.
The results may help clinicians identify high-risk patients, improve the timing of intervention and source control, support discussions with patients and families, and develop future risk-prediction models for anastomotic leak outcomes.
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. Histologically confirmed or clinically suspected primary colorectal adenocarcinoma requiring surgical resection.
Undergoing elective or emergency colorectal resection with formation of a primary intestinal or colorectal anastomosis.
Anastomotic leakage diagnosed within 90 days after the index colorectal resection or during the index hospital admission.
Leak confirmed clinically, radiologically, endoscopically, through drainage of enteric contents, or during operative exploration.
Availability of sufficient medical records to determine the method of leak diagnosis, treatment, and short-term outcomes.
Ability to complete follow-up for stoma status, where applicable.
Exclusion Criteria:
* Age younger than 18 years. Colorectal operation performed for a benign condition without colorectal cancer.
Abdominoperineal excision or another procedure without formation of an intestinal anastomosis.
Local transanal tumour excision without colorectal anastomosis. Leakage involving only a urinary, vascular, or non-intestinal anastomosis. Planned permanent stoma without a colorectal or intestinal anastomosis. Anastomotic leak occurring after surgery for recurrent disease without resection of a primary colorectal tumour, unless specifically included in a predefined secondary cohort.
Inability to verify the diagnosis of anastomotic leakage. Inadequate data to determine all three primary outcomes. Refusal to participate where individual info…
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
Permanent Stoma
Timeframe: Twelve months after the index colorectal resection
2
Proportion of Participants Requiring Unplanned Rescue Surgery
Timeframe: Within 30 days after diagnosis of anastomotic leakage
3
Ninety-Day Mortality
Timeframe: Within 90 days after diagnosis of anastomotic leakage