Primary Anastomosis After Left Colectomy in Emergency Cases

Not Applicable

Completed

• Conditions: Complete Obstruction

• Registration Number: NCT07026201
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2024-03-20
• Primary Completion: 2024-03-20
• Study Completion: 2025-03-20
• Study First Submitted: 2025-04-26
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Anastomotic Leakage Within 30 Days Post-Operatively	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)
Incidence of Surgical Site Infection	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 Outcome Measures

Name	Time	Method
Incidence of Postoperative Ileus	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
Time to Restoration of Bowel Movement	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
Length of Hospital Stay	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
Readmission Rate Within 30 Days	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt