Can we predict who will survive a bowel surgery leak?
NCT ID NCT07725692
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This study looks at people who develop a leak after colorectal cancer surgery. Researchers will track which patients need emergency surgery, die within 90 days, or end up with a permanent stoma. The goal is to find factors that predict these outcomes and help guide future care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors identify high-risk patients earlier and improve decision-making after a leak, potentially reducing deaths and permanent stomas.
- What could go wrong
- This is an observational study, not a treatment trial, so it cannot prove cause and effect. Results may not apply to all hospitals or patient groups.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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3,200 people
The number who actually took part.
- Started
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May 2016
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adult patients treated at participating colorectal surgical centres who develop an anastomotic leak following colorectal cancer resection with primary anastomosis. Participants will be identified consecutively through operating theatre records, colorectal cancer databases, postoperative complication meetings, radiology records, reoperation records, intensive care databases, stoma-care services, and prospective notification by participating surgical teams.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 informed consent is required.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Study site
Alexandria, Please Select, 21111, Egypt
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