Naples, 80131, Italy
NCT Number: NCT07094594
ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
ostomy closure
Time frame: 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 outcomes
-
Quality of life, assessed using validated tools such as the SF-36
Time frame: 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).
Sponsors and collaborators
Lead sponsor
Azienda Sanitaria Locale Napoli 2 Nord
Other
Registry information
Official study title
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
Acronym: ARES
Important dates
- Study start
- 2017
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 30, 2025
- Registry last updated
- Aug 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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