NCT07144683 Anastomotic Leakage After Colorectal Surgery.
| NCT ID | NCT07144683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Anastomotic Leak |
| Study Type | OBSERVATIONAL |
| Enrollment | 430 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-08-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 430 participants in total. It began in 2025-08-25 with a primary completion date of 2026-08-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.
Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years * Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal) * Providing written informed consent Exclusion Criteria: * Colorectal resection without anastomosis (e.g., end stoma) * Inflammatory bowel disease (Crohn's, ulcerative colitis) * History of previous colorectal surgery involving anastomosis * Pregnancy * Unable to provide informed consent or comply with follow-up
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07144683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Anastomotic Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07144683 currently recruiting?
Yes, NCT07144683 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07144683 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07144683 clinical trial?
NCT07144683 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 430 participants.