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

NCT06794905 | Completed DMC

• 1 other identifier: 20252818
• Study Type: observational
• Target: 578
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diverticular Disease of Colon; Colostomy Complication; Colostomy - Stoma

Keywords

Hartmann; Diverticular Disease of colon; stoma

Outcome Measures

Primary Outcomes (1)

• Stoma closure within 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.

  24 months

Secondary Outcomes (2)

• Surgical Complications

  24 months

• Index Admission Outcomes

  24 months

Study Arms (2)

rimary Anastomosis with Diverting Loop Ileostomy Group

This group includes patients who underwent segmental resection of the sigmoid colon followed by primary end-to-end anastomosis, protected by a diverting loop ileostomy. The surgical approach aimed to restore bowel continuity while minimizing the risk of anastomotic leakage through the protective ileostomy. Patients in this group were typically stable at the time of surgery, with no life-threatening sepsis or severe hemodynamic instability. Key metrics evaluated included stoma reversal rates, time to stoma closure, postoperative complications (both surgical and systemic), length of hospital stay, and quality of life after recovery. The technical approach incorporated the double-stapling method for anastomosis, and structured follow-up was implemented to monitor for dehydration, electrolyte imbalances, and long-term outcomes such as hernias and recurrence.

Hartmann's Procedure Group

This group comprises patients who underwent segmental resection of the sigmoid colon with the creation of an end colostomy, leaving the distal rectal stump closed. Hartmann's procedure was performed primarily in patients with more severe clinical conditions, including those with significant sepsis or hemodynamic instability, where the risk of anastomotic complications was deemed unacceptably high. Outcomes assessed in this group included the rates of permanent colostomy, incidence of parastomal hernias, long-term complications related to the colostomy, and overall recovery metrics. Patients were evaluated for potential stoma reversal, although a significant proportion of individuals in this group retained a permanent stoma due to either clinical contraindications or patient preference. Structured follow-up focused on addressing colostomy-related challenges and minimizing complications.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults presenting with acute perforated sigmoid diverticulitis at five surgical centers across Italy, encompassing both academic and community hospitals. This population represents a diverse cohort of patients encountered in real-world clinical settings, allowing for a broad evaluation of outcomes across varying levels of healthcare infrastructure and expertise. Participants will be selected from patients admitted through emergency departments with a confirmed diagnosis of perforated sigmoid diverticulitis classified as Hinchey Stage III or IV. The population includes clinically stable individuals who are eligible for emergency surgical intervention and capable of undergoing either primary anastomosis with diverting loop ileostomy or Hartmann's procedure. The inclusion of patients from different regions and centers ensures a heterogeneous sample that reflects diverse demographic, socioeconomic, and clinical characteristics.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Related Publications (1)

• Rehmani S, Bhora F, Flores R. Robotic Lung Cancer Surgery: A Missed Opportunity and a Faulty Conclusion. Ann Surg. 2018 Feb;267(2):e34. doi: 10.1097/SLA.0000000000001996. No abstract available.

  PMID: 27643927 BACKGROUND

MeSH Terms

Conditions

Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD, Md

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 28, 2025

Record last verified: 2025-01