ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis

NCT07094594 | Completed

• 1 other identifier: 20251107
• Study Type: observational
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study was conducted across five surgical centers in Italy, including both academic and community hospitals, from January 2017 to December 2022. The study aimed to evaluate outcomes in patients with acute perforated sigmoid diverticulitis classified as Hinchey Stage III or IV. All consecutive patients aged 18 years or older who presented with acute perforated sigmoid diverticulitis and underwent emergency colonic resection were included. Patients were excluded if they had Hinchey Stage I or II diverticulitis, postoperative confirmation of malignancy, or underwent laparoscopic surgery. This approach ensured a well-defined patient cohort for consistent and reliable analysis.

Conditions

Diverticular Disease of Colon; Colostomy - Stoma; Loop Ileostomies

Keywords

diverticular disease of colon; Hartmann; loop ileostomies

Outcome Measures

Primary Outcomes (1)

• ostomy closure

  The primary endpoint was ostomy closure within 24 months, defined as the successful reversal of the stoma. This outcome was chosen as a measure of complete care, reflecting the restoration of bowel continuity and functionality.

  24 mounths

Secondary Outcomes (1)

• Quality of life, assessed using validated tools such as the SF-36

  24 months

Study Arms (2)

Hartmann's Procedure Hartmann's Procedure (HP)

Hartmann's Procedure (Hartmann's Procedure (HP)): Segmental resection of the sigmoid colon with the creation of an end colostomy.

Primary Anastomosis and Diverting Loop Ileostomy (PADLI)

Primary Anastomosis and Diverting Loop Ileostomy (PADLI): Segmental resection followed by end-to-end anastomosis, protected by a diverting loop ileostomy.

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 adult patients (≥18 years) who presented with acute perforated sigmoid diverticulitis (PSD) classified as Hinchey Stage III or IV and underwent emergency open colonic resection. All participants were clinically stable at the time of surgery and were eligible to receive either primary anastomosis with diverting loop ileostomy (PADLI) or Hartmann's procedure (HP). Patients with Hinchey Stage I-II diverticulitis, postoperative confirmation of malignancy, laparoscopic surgery, or hemodynamic instability were excluded to ensure a well-defined and homogeneous study cohort for consistent outcome analysis.

You may qualify if:

• Adults aged ≥18 years
• Clinical diagnosis of perforated sigmoid diverticulitis (Hinchey Stage III or IV)
• Clinically stable and suitable for undergoing emergency colonic resection
• Eligible to receive either primary anastomosis with diverting loop ileostomy or Hartmann's procedure
• Informed consent provided by the patient or a legal surrogate

You may not qualify if:

• Hinchey Stage I or II diverticulitis
• Postoperative confirmation of malignancy as the primary cause of perforation
• Laparoscopic surgery instead of open colonic resection
• Unstable patients with severe sepsis, septic shock, or significant hemodynamic compromise

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Unknown Facility

Napoli, 80131, Italy

Location

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

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: January 1, 2017
• Primary Completion: January 1, 2025
• Study Completion: March 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)