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Completed

NCT Number: NCT07026201

Primary Anastomosis After Left Colectomy in Emergency Cases

The aim of this study is to know the outcome of primary anastomosis after left colectomy in emergency cases regarding early post operative complication like surgical site infection , ileus, incidence of leakage, restoration of bowel movement and hospital stay and rate of readmission within one month from the time of intervention.

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Key information

Conditions

Complete Obstruction Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting to the emergency department with obstructed left colon
  • Patients aged between 18 and 80 years old
  • Decision of laparotomy is made
  • Intraoperative conditions are favorable for anastomosis (e.g., good vascularity, no severe sepsis, no marked tissue edema, no thickened peritoneum)
  • Patient agrees to participate in the study

Exclusion criteria

  • Severe diffuse peritonitis (e.g., peritoneal thickening, thickened bowel loop, severe tissue edema, and pyogenic membrane)
  • Marked decreased tissue vascularity due to distension
  • Irresectable mass
  • Rectal mass
  • Patients refusing to participate in the study

Treatment and study plan

colectomy with primary anastomosis

Other

left hemicolectomy or sigmoidectomy, formal resection was carried out following conventional steps of radical resection.with primary anastomosis

Other names: surgical management

Primary outcomes

  1. Incidence of Anastomotic Leakage Within 30 Days Post-Operatively

    Time frame: 30 days after surgery

    • Description: Percentage of patients who develop an anastomotic leak as diagnosed clinically or radiologically
    • Unit of Measure: % of patients
    • Assessment Method: Clinical signs and imaging (e.g., contrast-enhanced CT scan)

  2. Incidence of Surgical Site Infection

    Time frame: 30 days after surgery

    • Description: Percentage of patients who develop a surgical site infection within 30 days after the operation
    • Unit of Measure: % of patients
    • Assessment Method: Clinical evaluation and/or positive wound culture

Secondary outcomes

  1. Incidence of Postoperative Ileus

    Time frame: From date of surgery until first bowel movement, assessed up to 7 days post-surgery

    • Description: Percentage of patients who experience postoperative ileus, defined as absence of bowel movement and need for nasogastric tube beyond 3 days post-surgery
    • Unit of Measure: % of patients
    • Assessment Method: Clinical observation and medical records

  2. Time to Restoration of Bowel Movement

    Time frame: Assessed up to 7 days post-surgery

    • Description: Number of days until first recorded bowel movement after surgery
    • Unit of Measure: Days
    • Assessment Method: Patient report and nursing documentation

  3. Length of Hospital Stay

    Time frame: Assessed up to 14 days post-surgery

    • Description: Total number of days the patient remained in hospital after surgery
    • Unit of Measure: Days
    • Assessment Method: Hospital records

  4. Readmission Rate Within 30 Days

    Time frame: Time Frame: 30 days post-surgery

    • Description: Percentage of patients readmitted to any hospital within 30 days after initial discharge
    • Unit of Measure: % of patients
    • Assessment Method: Patient follow-up and hospital readmission records

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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