Comparing Hartmann's Procedure and Primary Resection with Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes

NCT06794905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 578

Last updated 2025-01-28

No results posted yet for this study

Summary

Brief Summary

This multicenter study compares the effectiveness of primary anastomosis with diverting loop ileostomy to Hartmann's procedure for managing perforated sigmoid diverticulitis in stable patients. The findings demonstrate that primary anastomosis with diverting loop ileostomy offers superior long-term outcomes, including higher stoma reversal rates (92% versus 58%), shorter time to closure, and fewer parastomal hernias, contributing to improved quality of life. Kaplan-Meier analysis further supports the benefits of primary anastomosis with diverting loop ileostomy, showing significantly better stoma-free survival rates at 24 months. Despite higher short-term readmission rates due to ileostomy-related complications, patients undergoing primary anastomosis with diverting loop ileostomy experienced shorter hospital stays and fewer long-term complications compared to patients undergoing Hartmann's procedure. While Hartmann's procedure remains crucial for unstable cases, the functional and psychological advantages of primary anastomosis with diverting loop ileostomy underscore its value for stable patients. Future research should focus on randomized trials and minimally invasive approaches to refine surgical strategies.

Conditions

  • Diverticular Disease of Colon
  • Colostomy Complication
  • Colostomy - Stoma

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794905 on ClinicalTrials.gov