Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticu… (NCT06794905) | Clinical Trial Compass
CompletedNot Applicable
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
578 participantsStarted 2017-01-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.