ClinicalTrials.gg
Sign In
RecruitingNCT07144683ALUpdated Nov 10, 2026

Anastomotic Leakage After Colorectal Surgery.

An observational study in Anastomotic Leak, Colorectal Cancer and Diverticulitis, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Minia University · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Nov 10, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
430
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Anastomotic leakage (AL) remains a major complication after colorectal surgery, contributing to morbidity, mortality, prolonged hospital stays, and increased costs. Its etiology is multifactorial, involving patient, disease, and surgical factors. This study will prospectively evaluate risk factors in a single-center setting to minimize variability.

AL definition (per ISGRC): Defect at anastomotic site causing communication between intra/extraluminal compartments and luminal tract, diagnosed via clinical signs (e.g., peritonitis, fecal discharge), radiological evidence (e.g., CT showing extraluminal air/contrast or fluid collection), or operative verification.

Severity grading:

  • Grade A: Asymptomatic/mild, no active treatment.
  • Grade B: Requires intervention (e.g., drainage, antibiotics) but no reoperation.
  • Grade C: Requires reoperation.

Risk factors categorized as:

  • Preoperative: Demographics (age, sex, BMI), comorbidities (ASA score, diabetes....), lifestyle (smoking, alcohol), nutritional status (albumin, CRP), neoadjuvant therapy, medications, diagnosis (e.g., cancer, tumor location), and bowel preparation.
  • Intraoperative: Approach (open/laparoscopic), resection type, anastomosis details (hand-sewn/stapled, level, perfusion assessment), peritoneal soiling, diverting stoma, operative time, blood loss/transfusion, drainage, surgeon experience, complications.
  • Postoperative: AL diagnosis/severity/management, inflammatory response (CRP, WBC), anemia, complications (ileus, infection), hospital stay, nutritional support, mobilization, reoperation, ICU stay, mortality, pain management.Early detection of leak using inflammatory markers either in the serum or drain fluid. Drain fluid inflammatory markers (Drain Fluid Calprotectin(CP), Drain Fluid C-Reactive Protein (CRP), Drain Fluid Procalcitonin)and Serum inflammatory markers(Serum C-Reactive Protein (CRP), Serum Procalcitonin (PCT), Serum Lactate dehydrogenase (LDH)).

Data from electronic records, surgical notes, nursing charts, and follow-up. Statistical analysis includes descriptive stats, univariate/multivariate logistic regression for risk factors, subgroup analyses, and predictive model development/validation.

The study adheres to the Helsinki Declaration and Good Clinical Practice (GCP). Informed consent is required.

02

Conditions studied

  • Anastomotic Leak
  • Colorectal Cancer
  • Diverticulitis

Keywords

  • Anastomotic leakage
  • Colorectal surgery
  • Risk factors
  • Postoperative complications
  • Predictive model
03

In context

Anastomotic Leak

240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.

This study's planned enrollment of 430 is above the median of 166 across 111 observational studies indexed under Anastomotic Leak.

Browse Anastomotic Leak studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Minia University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal). No intervention; observational only. Risk factors and outcomes will be monitored prospectively.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥18 years
  • Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)
  • Providing written

Exclusion criteria

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 or comply with follow-up
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
430 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Patients Undergoing Colorectal Resection with Anastomosis

    All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal). Risk factors and outcomes will be monitored prospectively.

    Procedure: Patients Undergoing Colorectal Resection with Anastomosis

Interventions

  • ProcedurePatients Undergoing Colorectal Resection with Anastomosis

    All eligible patients undergoing elective/emergency colorectal surgery with primary anastomosis (e.g., ileocolic, colocolic, colorectal, or coloanal)

06

What researchers measure

Primary outcomes

  1. Incidence of Anastomotic Leakage (AL)

    Proportion of patients developing AL within 30 days post-surgery or during hospital stay (whichever longer), diagnosed clinically, radiologically, or operatively per ISGRC definition

    Time frame: Within 30 days post-surgery.

Secondary outcomes

  1. Severity of Anastomotic Leakage

    Graded as A (asymptomatic/mild, no treatment), B (requires intervention, no reoperation), or C (requires reoperation) per ISGRC.

    Time frame: Within 30 days post-surgery

  2. Reoperation Rate Due to AL

    Proportion of patients requiring reoperation for AL.

    Time frame: Within 30 days post-surgery

  3. Readmission Rate Due to AL

    Proportion of patients readmitted for AL-related issues.

    Time frame: Within 30 days post-surgery

  4. Length of Hospital Stay

    Duration of hospitalization (days) for patients with vs. without AL.

    Time frame: Within 30 days post-surgery.

  5. Mortality Rate

    30-day and in-hospital mortality.

    Time frame: Within 30 days post-surgery.

  6. Need for Permanent Stoma

    Proportion of patients requiring permanent stoma due to AL.

    Time frame: Within 90 days post-surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Aug 25, 2026→Mar 25, 2027
Nov 10, 2026
Study completion
Sep 25, 2026→Apr 25, 2027
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Primary completion Aug 25, 2026→Mar 25, 2027
    Study completion Sep 25, 2026→Apr 25, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07144683
Lead sponsor
Minia University
Responsible party
Saleh Khairy Saleh MD (Lecturer, Minia University) — Principal investigator
First posted
Aug 27, 2025
Start date
Aug 25, 2025
Primary completion
Mar 25, 2027 (estimated)
Completion
Apr 25, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Saleh K Saleh, MD
Contact
salehkhairy@mu.edu.eg
01201765401 ext. +2
Saleh K Saleh, MD
principal investigator · Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Anastomotic Leak →

Other studies from this sponsor

Minia University →

Start the discussion