Predictors of Rescue Surgery, Mortality, and Permanent Stoma After Anastomotic Leak Following Colorectal Cancer Resection

NCT07725692 | Completed DMC

• 1 other identifier: 0308007
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anastomotic Leak; Colorectal Cancer; Colon Cancer; Postoperative Complication; Intestinal Stoma

Keywords

Rectal cancer; colon cancer; anastomotic leak; stoma; Postoperative mortality; Failure to rescue

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Within 90 days after diagnosis of anastomotic leakage

Secondary Outcomes (11)

• Failure to Rescue

  Within 90 days after anastomotic leak diagnosis

• Anastomotic Salvage

  Twelve months after the index operation

• Stoma Reversal

  Up to 24 months after the index operation

• Time to Stoma Reversal

  From index colorectal resection to stoma reversal, up to 24 months

• Intensive Care Unit Admission

  From leak diagnosis to 30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Unknown Facility

Alexandria, Please Select, 21111, Egypt

Location

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms; Colonic Neoplasms; Postoperative Complications; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 24, 2026
• Study Start: May 1, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-04

Locations

EG (1)