Anastomotic Leakleak predictorNCT07725692
Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
An observational study of Anastomotic Leak and Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Colorectal Cancer, Colon Cancer
- How many people
- 3,200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2016to 1 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anastomotic Leak, Colorectal Cancer, Colon Cancer, Postoperative Complication, Intestinal Stoma
- Keywords
- Rectal cancer, colon cancer, anastomotic leak, stoma, Postoperative mortality, Failure to rescue
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms, Colonic Neoplasms, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients With Anastomotic Leak Following Colorectal Cancer Resection | Consecutive adult patients who develop a clinically, radiologically, endoscopically, or operatively confirmed anastomotic leak following colorectal cancer resection with formation of a primary colorectal, coloanal, ileocolic, colocolic, or ileorectal anastomosis. Participants will receive routine diagnostic and therapeutic management determined by their treating surgical teams. No intervention will be assigned by the investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent Stoma
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.
Measured: Twelve months after the index colorectal resection
Proportion of Participants Requiring Unplanned Rescue Surgery
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.
Measured: Within 30 days after diagnosis of anastomotic leakage
Ninety-Day Mortality
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.
Measured: Within 90 days after diagnosis of anastomotic leakage
Secondary outcomes (11)
Failure to Rescue
Death within 90 days following anastomotic leakage among patients who developed the complication.
Measured: Within 90 days after anastomotic leak diagnosis
Anastomotic Salvage
Proportion of participants in whom the original anastomosis remains in place and intestinal continuity has been maintained or restored without a permanent stoma.
Measured: Twelve months after the index operation
Stoma Reversal
Proportion of participants undergoing successful reversal of a diverting or leak-related ileostomy or colostomy.
Measured: Up to 24 months after the index operation
Time to Stoma Reversal
Number of days between the index colorectal cancer operation and successful restoration of intestinal continuity.
Measured: From index colorectal resection to stoma reversal, up to 24 months
Intensive Care Unit Admission
Admission or readmission to an intensive care unit as a consequence of the anastomotic leak or its treatment.
Measured: From leak diagnosis to 30 days
Organ Support
Requirement for vasopressor therapy, invasive mechanical ventilation, or renal replacement therapy.
Measured: Within 30 days after leak diagnosis
Number of Reinterventions
Total number of operative, radiological, endoscopic, and transanal interventions required for management of the anastomotic leak.
Measured: Within 90 days after leak diagnosis
Length of Hospital Stay
Total duration of hospitalization associated with the index operation and anastomotic leak.
Measured: From index colorectal resection to discharge in 7 days to 30 days
Hospital Readmission
Any unplanned hospital readmission related to the anastomotic leak, stoma, infection, or postoperative recovery.
Measured: Within 90 days after the index colorectal resection
Delay in Adjuvant Cancer Treatment
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.
Measured: Within six months after the index operation
Permanent Stoma at 24 Months
Presence of an ileostomy or colostomy at 24 months or a documented decision that reversal will not be attempted.
Measured: Twenty-four months after the index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 May 2016
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725692
- Sponsor's protocol ID
- 0308007
- Acronym
- leak predictor
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection
- ClinicalTrials.gov ID
- NCT07725692
- Acronym / sponsor ID
- leak predictor / 0308007
- Conditions
- Anastomotic Leak, Colorectal Cancer, Colon Cancer, Postoperative Complication, Intestinal Stoma
- Keywords
- Rectal cancer, colon cancer, anastomotic leak, stoma, Postoperative mortality, Failure to rescue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients With Anastomotic Leak Following Colorectal Cancer Resection | – | –Consecutive adult patients who develop a clinically, radiologically, endoscopically, or operatively confirmed anastomotic leak following colorectal cancer resection with formation of a primary colorectal, coloanal, ileocolic, colocolic, or ileorectal anastomosis. Participants will receive routine diagnostic and therapeutic management determined by their treating surgical teams. No intervention will be assigned by the investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
11 secondary outcomes
Failure to Rescue
Time frame: Within 90 days after anastomotic leak diagnosis
Anastomotic Salvage
Time frame: Twelve months after the index operation
Stoma Reversal
Time frame: Up to 24 months after the index operation
Time to Stoma Reversal
Time frame: From index colorectal resection to stoma reversal, up to 24 months
Intensive Care Unit Admission
Time frame: From leak diagnosis to 30 days
Organ Support
Time frame: Within 30 days after leak diagnosis
Number of Reinterventions
Time frame: Within 90 days after leak diagnosis
Length of Hospital Stay
Time frame: From index colorectal resection to discharge in 7 days to 30 days
Hospital Readmission
Time frame: Within 90 days after the index colorectal resection
Delay in Adjuvant Cancer Treatment
Time frame: Within six months after the index operation
Permanent Stoma at 24 Months
Time frame: Twenty-four months after the index operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak and Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent Stoma (time frame: Twelve months after the index colorectal resection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.