Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).

Stoma Ileostomy Clinical Trial

— SIGMA-D  

Official title:

Surgical Italian Guide for the Management of Complicated Acute Diverticulitis in Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06344078
• Other study ID #: SIGMA-d
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• 18 yo or older
• CT scan and WSES classification
• surgical intervention within 48 hours for acute diverticulitis

Exclusion Criteria:

• underaged
• conservative treatment for acute diverticulitis
• other treatment
• diagnosis of colorectal cancer at histology

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis
• Emergencies
• Stoma Colostomy
• Stoma Ileostomy

Intervention

Procedure:
• sigmoid resection and anastomosis / stoma
intestinal resection and recostruction or creation of stoma

Locations

Country	Name	City	State
Italy	Azienda ospedaliera universitaria paolo giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adhesion to guidelines	assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.	1 year follow-up
Secondary	stoma reversal	understanding of the management of patients with stomas resulting from Hartmann's procedures or resection with primary anastomosis and protective stomas.	1 year follow-up