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

Completed

• Conditions: Diverticular Disease of Colon; Colostomy Complication; Colostomy - Stoma

• Registration Number: NCT06794905
• Lead Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Brief 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.

Detailed Description

Detailed Description

This multicenter study evaluates and compares the outcomes of primary anastomosis with diverting loop ileostomy and Hartmann's procedure in the surgical management of perforated sigmoid diverticulitis in stable patients. Conducted across multiple surgical centers, the study provides a comprehensive overview of these approaches in real-world clinical settings. The findings indicate that primary anastomosis with diverting loop ileostomy demonstrates significant advantages over Hartmann's procedure, particularly in terms of long-term outcomes, stoma management, and recovery metrics.

Patients who underwent primary anastomosis with diverting loop ileostomy achieved notably higher stoma reversal rates (92% versus 58%), a shorter median time to stoma closure, and fewer stoma-related complications such as parastomal hernias. These results underscore the benefits of restoring bowel continuity, which plays a critical role in improving both physical functionality and psychological well-being. Kaplan-Meier analysis confirmed superior stoma-free survival rates at 24 months for patients receiving primary anastomosis with diverting loop ileostomy compared to those treated with Hartmann's procedure.

While Hartmann's procedure remains a valuable option for unstable or critically ill patients due to its simplicity, its long-term disadvantages include a higher prevalence of stoma-related complications, such as parastomal hernias and challenges with colostomy management. Conversely, primary anastomosis with diverting loop ileostomy was associated with a slightly higher rate of early readmissions, often due to issues related to the protective ileostomy, including dehydration and electrolyte imbalances. However, these complications were generally manageable with appropriate follow-up care.

The study also highlights shorter hospital stays and faster recovery times for patients treated with primary anastomosis with diverting loop ileostomy, contributing to reduced healthcare costs and improved quality of life. These findings suggest that primary anastomosis with diverting loop ileostomy should be considered a first-line option for stable patients, with Hartmann's procedure reserved for those in critical conditions. Future research is recommended to further investigate minimally invasive techniques, long-term quality of life outcomes, and randomized controlled trials to solidify these findings and refine surgical practices.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-25
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

Inclusion Criteria

• Adults aged 18 years or older.
• Diagnosed with perforated sigmoid diverticulitis classified as Hinchey Stage III or IV.
• Clinically stable patients suitable for emergency colonic resection.
• Eligible to undergo either primary anastomosis with diverting loop ileostomy or Hartmann's procedure.
• Provided informed consent or had a legal surrogate able to consent on their behalf.

Exclusion Criteria

• Hinchey Stage I or II diverticulitis, typically managed conservatively or with less invasive interventions.
• Postoperative confirmation of malignancy as the primary cause of the perforation.
• Undergoing laparoscopic surgery rather than open resection.
• Clinically unstable patients with severe sepsis, septic shock, or significant hemodynamic compromise.
• Pre-existing stomas or prior colonic resections.
• Significant comorbidities, such as advanced cardiac or respiratory failure.
• Limited life expectancy due to terminal illnesses (e.g., advanced malignancies).
• Inability to participate in follow-up assessments due to cognitive impairments or logistical barriers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stoma closure within 24 months	24 months	This outcome was chosen for its significant impact on patient quality of life and its role in reflecting the resolution of temporary stomas created during the initial surgery. Achieving stoma closure minimizes long-term stoma-related complications such as parastomal hernias, psychosocial distress, and reduced functionality. The study evaluates not only whether stoma closure occurs but also the time to closure, perioperative complications, and factors influencing closure feasibility, offering a comprehensive view of patient recovery.

Secondary Outcome Measures

Name	Time	Method
Surgical Complications	24 months	Surgery-specific complications: Rates of anastomotic leaks, intra-abdominal abscesses, surgical site infections, delayed healing, and hemorrhage.
Index Admission Outcomes	24 months	Length of hospital stay, stratified by procedure type.