Diverticular Disease of ColonARESNCT06794905
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
An observational study of Diverticular Disease of Colon and Colostomy Complication, run by Azienda Sanitaria Locale Napoli 2 Nord.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon, Colostomy Complication, Colostomy - Stoma
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2022
- 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 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
Detailed Description
This multicenter study evaluates and compares the outcomes of primary anastomosis with diverting loop ileostomy and Hartmann's procedure in the surgical management of perforated sigmoid diverticulitis in stable patients. Conducted across multiple surgical centers, the study provides a comprehensive overview of these approaches in real-world clinical settings. The findings indicate that primary anastomosis with diverting loop ileostomy demonstrates significant advantages over Hartmann's procedure, particularly in terms of long-term outcomes, stoma management, and recovery metrics.
Patients who underwent primary anastomosis with diverting loop ileostomy achieved notably higher stoma reversal rates (92% versus 58%), a shorter median time to stoma closure, and fewer stoma-related complications such as parastomal hernias. These results underscore the benefits of restoring bowel continuity, which plays a critical role in improving both physical functionality and psychological well-being. Kaplan-Meier analysis confirmed superior stoma-free survival rates at 24 months for patients receiving primary anastomosis with diverting loop ileostomy compared to those treated with Hartmann's procedure.
While Hartmann's procedure remains a valuable option for unstable or critically ill patients due to its simplicity, its long-term disadvantages include a higher prevalence of stoma-related complications, such as parastomal hernias and challenges with colostomy management. Conversely, primary anastomosis with diverting loop ileostomy was associated with a slightly higher rate of early readmissions, often due to issues related to the protective ileostomy, including dehydration and electrolyte imbalances. However, these complications were generally manageable with appropriate follow-up care.
The study also highlights shorter hospital stays and faster recovery times for patients treated with primary anastomosis with diverting loop ileostomy, contributing to reduced healthcare costs and improved quality of life. These findings suggest that primary anastomosis with diverting loop ileostomy should be considered a first-line option for stable patients, with Hartmann's procedure reserved for those in critical conditions. Future research is recommended to further investigate minimally invasive techniques, long-term quality of life outcomes, and randomized controlled trials to solidify these findings and refine surgical practices.
- Keywords
- Hartmann, Diverticular Disease of colon, stoma
- 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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Surgical Complications
Surgery-specific complications: Rates of anastomotic leaks, intra-abdominal abscesses, surgical site infections, delayed healing, and hemorrhage.
Measured: 24 months
Index Admission Outcomes
Length of hospital stay, stratified by procedure type.
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 posted27 Jan 2025
- Study start1 Jan 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT06794905
- Sponsor's protocol ID
- 20252818
- Acronym
- ARES
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will include all de-identified individual participant data (IPD) supporting the results, such as demographic, clinical, surgical, and follow-up information, including quality of life and long-term follow-up data. A decision on IPD sharing is pending, considering patient privacy, data ownership, and compliance with GDPR and ethical regulations. Data sharing may be possible upon reasonable request to qualified researchers through secure agreements after further evaluation.
Publications
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.
PubMed 27643927
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 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
- NCT06794905
- Acronym / sponsor ID
- ARES / 20252818
- Keywords
- Hartmann, Diverticular Disease of colon, stoma
- 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
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Jan 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.
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.
Detailed description
Detailed Description
This multicenter study evaluates and compares the outcomes of primary anastomosis with diverting loop ileostomy and Hartmann's procedure in the surgical management of perforated sigmoid diverticulitis in stable patients. Conducted across multiple surgical centers, the study provides a comprehensive overview of these approaches in real-world clinical settings. The findings indicate that primary anastomosis with diverting loop ileostomy demonstrates significant advantages over Hartmann's procedure, particularly in terms of long-term outcomes, stoma management, and recovery metrics.
Patients who underwent primary anastomosis with diverting loop ileostomy achieved notably higher stoma reversal rates (92% versus 58%), a shorter median time to stoma closure, and fewer stoma-related complications such as parastomal hernias. These results underscore the benefits of restoring bowel continuity, which plays a critical role in improving both physical functionality and psychological well-being. Kaplan-Meier analysis confirmed superior stoma-free survival rates at 24 months for patients receiving primary anastomosis with diverting loop ileostomy compared to those treated with Hartmann's procedure.
While Hartmann's procedure remains a valuable option for unstable or critically ill patients due to its simplicity, its long-term disadvantages include a higher prevalence of stoma-related complications, such as parastomal hernias and challenges with colostomy management. Conversely, primary anastomosis with diverting loop ileostomy was associated with a slightly higher rate of early readmissions, often due to issues related to the protective ileostomy, including dehydration and electrolyte imbalances. However, these complications were generally manageable with appropriate follow-up care.
The study also highlights shorter hospital stays and faster recovery times for patients treated with primary anastomosis with diverting loop ileostomy, contributing to reduced healthcare costs and improved quality of life. These findings suggest that primary anastomosis with diverting loop ileostomy should be considered a first-line option for stable patients, with Hartmann's procedure reserved for those in critical conditions. Future research is recommended to further investigate minimally invasive techniques, long-term quality of life outcomes, and randomized controlled trials to solidify these findings and refine surgical practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
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 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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
Stoma closure within 24 months
Time frame: 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.
2 secondary outcomes
Surgical Complications
Time frame: 24 months
Index Admission Outcomes
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 28 Jan 2025.
- Results publication: PubMed 27643927Rehmani 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.
- Individual participant dataSharing planned: Undecided. The study will include all de-identified individual participant data (IPD) supporting the results, such as demographic, clinical, surgical, and follow-up information, including quality of life and long-term follow-up data. A decision on IPD sharing is pending, considering patient privacy, data ownership, and compliance with GDPR and ethical regulations. Data sharing may be possible upon reasonable request to qualified researchers through secure agreements after further evaluation.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Colon and Colostomy Complication, run by Azienda Sanitaria Locale Napoli 2 Nord.
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 8 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Stoma closure within 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06794905, which also lists 1 linked publication.
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 28 Jan 2025.