ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07094594

Acronym

ARES

Enrollment

578

Registered

2025-07-30

Start date

2017-01-01

Completion date

2025-03-30

Last updated

2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy - Stoma, Diverticular Disease of Colon, Loop Ileostomies

Keywords

diverticular disease of colon, Hartmann, loop ileostomies

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.

Detailed description

This multicenter, prospective observational study evaluated clinical outcomes in adult patients with acute perforated sigmoid diverticulitis classified as Hinchey Stage III or IV, who underwent emergency open colonic resection in five surgical centers in Italy. The study period extended from January 2017 to December 2022 and involved both academic and community hospitals, providing a representative overview of real-world surgical practice. All consecutive patients aged 18 years or older with a clinical and radiological diagnosis of Hinchey III-IV perforated sigmoid diverticulitis were considered for inclusion. Eligible patients were required to be clinically stable at presentation, enabling them to undergo either primary anastomosis with diverting loop ileostomy or Hartmann's procedure , based on surgeon judgment and intraoperative findings. Exclusion criteria included: * Hinchey Stage I or II diverticulitis * Postoperative confirmation of malignancy as the primary cause of the perforation * Laparoscopic procedures instead of open resections * Patients with severe hemodynamic instability, septic shock, or uncontrolled sepsis The primary objective was to compare short- and long-term outcomes between primary anastomosis with diverting loop ileostomy and Hartmann's procedure, including postoperative morbidity and mortality, quality of life, stoma reversal rates, and hospital readmissions. Secondary endpoints included surgical site infections, length of hospital stay, and long-term complications such as parastomal hernia. This structured design ensured a well-defined and homogeneous study cohort for outcome comparison, allowing for the generation of meaningful real-world evidence on the optimal surgical management of complicated diverticulitis.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
ostomy closure	24 mounths	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.

Secondary

Measure	Time frame	Description
Quality of life, assessed using validated tools such as the SF-36	24 months	Quality of life will be evaluated using the Short Form Health Survey (SF-36), a validated questionnaire assessing physical and mental health. The SF-36 score ranges from 0 to 100, with higher scores indicating better quality of life across its domains (physical functioning, role limitations, pain, general health, vitality, social functioning, and mental health).

Countries

Italy

Outcome results