Alexandria, Please Select, 21111, Egypt
NCT Number: NCT07725692
Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Anastomotic leakage following colorectal cancer resection is associated with substantial postoperative morbidity and mortality. Although several management strategies are available-including antibiotics, image-guided drainage, endoscopic treatment, transanal drainage, proximal diversion, operative washout, anastomotic revision, and dismantling of the anastomosis-the clinical course varies considerably between patients.
Early identification of patients who are likely to require operative rescue, die following the leak, or remain with a permanent stoma may improve clinical decision-making. However, the predictors of these outcomes have not been sufficiently defined across different colorectal resections, anastomotic levels, leak presentations, and treatment strategies.
This study will include consecutive adult patients with colorectal cancer who develop a confirmed anastomotic leak after colorectal resection with primary anastomosis.
Anastomotic leakage will be defined as a defect in the intestinal wall at the anastomotic site resulting in communication between the intraluminal and extraluminal compartments. The diagnosis may be established clinically, radiologically, endoscopically, or operatively.
For this study, "rescue surgery" means an unplanned operative intervention performed for control or treatment of the anastomotic leak. It may include laparoscopy or laparotomy, abdominal or pelvic washout, operative drainage, anastomotic repair or revision, proximal diversion, or dismantling of the anastomosis with formation of an end stoma.
The decision to perform rescue surgery or any other treatment will remain entirely at the discretion of the treating clinical team. Participation in the study will not alter routine management.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Permanent Stoma
Time frame: Twelve months after the index colorectal resection
The presence of an ileostomy or colostomy 12 months after the index colorectal cancer operation, or documentation that restoration of intestinal continuity will not be attempted because of technical, medical, oncological, functional, or patient-related factors.
Patients who die before the 12-month assessment will be recorded separately and considered as competing events in time-to-stoma-reversal analyses.
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Proportion of Participants Requiring Unplanned Rescue Surgery
Time frame: Within 30 days after diagnosis of anastomotic leakage
The proportion of participants undergoing an unplanned operative intervention for treatment or source control of the anastomotic leak.
Rescue surgery includes operative washout, surgical drainage, anastomotic repair, anastomotic revision, proximal diversion, takedown of the anastomosis, or formation of an end stoma. Image-guided, endoscopic, or transanal procedures performed without general or regional operative exploration will be recorded separately and will not constitute rescue surgery for the primary outcome.
-
Ninety-Day Mortality
Time frame: Within 90 days after diagnosis of anastomotic leakage
Death from any cause occurring within 90 days after the date on which the anastomotic leak was first confirmed. In-hospital deaths occurring beyond 90 days will also be reported separately.
Secondary outcomes
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Failure to Rescue
Time frame: Within 90 days after anastomotic leak diagnosis
Death within 90 days following anastomotic leakage among patients who developed the complication.
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Anastomotic Salvage
Time frame: Twelve months after the index operation
Proportion of participants in whom the original anastomosis remains in place and intestinal continuity has been maintained or restored without a permanent stoma.
-
Stoma Reversal
Time frame: Up to 24 months after the index operation
Proportion of participants undergoing successful reversal of a diverting or leak-related ileostomy or colostomy.
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Time to Stoma Reversal
Time frame: From index colorectal resection to stoma reversal, up to 24 months
Number of days between the index colorectal cancer operation and successful restoration of intestinal continuity.
-
Intensive Care Unit Admission
Time frame: From leak diagnosis to 30 days
Admission or readmission to an intensive care unit as a consequence of the anastomotic leak or its treatment.
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Organ Support
Time frame: Within 30 days after leak diagnosis
Requirement for vasopressor therapy, invasive mechanical ventilation, or renal replacement therapy.
-
Number of Reinterventions
Time frame: Within 90 days after leak diagnosis
Total number of operative, radiological, endoscopic, and transanal interventions required for management of the anastomotic leak.
-
Length of Hospital Stay
Time frame: From index colorectal resection to discharge in 7 days to 30 days
Total duration of hospitalization associated with the index operation and anastomotic leak.
-
Hospital Readmission
Time frame: Within 90 days after the index colorectal resection
Any unplanned hospital readmission related to the anastomotic leak, stoma, infection, or postoperative recovery.
-
Delay in Adjuvant Cancer Treatment
Time frame: Within six months after the index operation
Time from colorectal cancer resection to initiation of indicated adjuvant chemotherapy, and the proportion of patients unable to receive planned adjuvant treatment because of the leak or its consequences.
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Permanent Stoma at 24 Months
Time frame: Twenty-four months after the index operation
Presence of an ileostomy or colostomy at 24 months or a documented decision that reversal will not be attempted.
Sponsors and collaborators
Lead sponsor
Alexandria University
Other
Registry information
Acronym: leak predictor
Important dates
- Study start
- 2016
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 24, 2026
- Registry last updated
- Jul 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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