Diverticular Disease of ColonARESNCT07094594
ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis
An observational study of Diverticular Disease of Colon and Colostomy - Stoma, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon, Colostomy - Stoma, Loop Ileostomies
- How many people
- 578 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
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.
Read the 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.
- Keywords
- diverticular disease of colon, Hartmann, loop ileostomies
- Medical subject headings
- Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 mounths
Secondary outcomes (1)
Quality of life, assessed using validated tools such as the SF-36
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2017
- Primary completion1 Jan 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular Disease of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094594
- Sponsor's protocol ID
- 20251107
- Acronym
- ARES
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The decision not to share IPD is based on institutional policies and ethical considerations related to patient confidentiality and data protection. Additionally, no data-sharing infrastructure has been established within the current study protocol, and there are no plans at this time to develop such a framework.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
- ClinicalTrials.gov ID
- NCT07094594
- Acronym / sponsor ID
- ARES / 20251107
- Keywords
- diverticular disease of colon, Hartmann, loop ileostomies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quality of life, assessed using validated tools such as the SF-36
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The decision not to share IPD is based on institutional policies and ethical considerations related to patient confidentiality and data protection. Additionally, no data-sharing infrastructure has been established within the current study protocol, and there are no plans at this time to develop such a framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Colon and Colostomy - Stoma, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ostomy closure (time frame: 24 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.