NCT07144683

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

August 14, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2026

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 14, 2025

Last Update Submit

September 5, 2025

Conditions

Anastomotic LeakColorectal CancerDiverticulitis

Keywords

Anastomotic leakageColorectal surgeryRisk factorsPostoperative complicationsPredictive model

Outcome Measures

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

    Within 30 days post-surgery.

Secondary Outcomes (6)

  • Severity of Anastomotic Leakage

    Within 30 days post-surgery

  • Reoperation Rate Due to AL

    Within 30 days post-surgery

  • Readmission Rate Due to AL

    Within 30 days post-surgery

  • Length of Hospital Stay

    Within 30 days post-surgery.

  • Mortality Rate

    Within 30 days post-surgery.

  • +1 more secondary outcomes

Study Arms (1)

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

Patients Undergoing Colorectal Resection with AnastomosisPROCEDURE

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

Patients Undergoing Colorectal Resection with Anastomosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Anastomotic LeakColorectal NeoplasmsDiverticulitisPostoperative Complications

Interventions

Anastomosis, Surgical

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesDiverticular DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Saleh K Saleh, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401salehkhairy@mu.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 14, 2025

First Posted

August 27, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

September 25, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)