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NCT06794905: ARES
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
trial in Diverticular Disease of Colon in 578 participants. Completed in 31 December 2022.
31 December 2022
Quick facts
| Lead sponsor | Azienda Sanitaria Locale Napoli 2 Nord |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 578 |
| Start date | 1 January 2017 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
Conditions studied
- Diverticular Disease of Colon — all drugs for Diverticular Disease of Colon →
- Colostomy Complication — all drugs for Colostomy Complication →
- Colostomy - Stoma — all drugs for Colostomy - Stoma →
Sponsor
Azienda Sanitaria Locale Napoli 2 Nord
Who can join
18 and older, any sex, with Diverticular Disease of Colon or Colostomy Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06794905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Diverticular Disease of Colon
Currently open trials in the same condition.
- NCT06764550 — Molecular and Microbiota Signatures Underlying Colonic Diverticular Disease · active not recruiting
Other Azienda Sanitaria Locale Napoli 2 Nord trials
Trials by the same sponsor.
- NCT07382180 — Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients · completed
- NCT04749329 — Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia. · NA · unknown
- NCT04471311 — Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Fie · NA · unknown
- NCT05632952 — ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials · unknown
- NCT07349628 — Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06794905 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Sanitaria Locale Napoli 2 Nord
- Last refreshed: 28 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06794905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing