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).

Recruiting

• Conditions: Stoma Colostomy; Stoma Ileostomy; Acute Diverticulitis
• Interventions: Procedure: sigmoid resection and anastomosis / stoma

• Registration Number: NCT06344078
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-04-03
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients operated for acute diverticulitis	sigmoid resection and anastomosis / stoma	patient with acute diverticulitis which are operated in urgency setting

Primary Outcome Measures

Name	Time	Method
adhesion to guidelines	1 year follow-up	assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.

Secondary Outcome Measures

Name	Time	Method
stoma reversal	1 year follow-up	understanding of the management of patients with stomas resulting from Hartmann's procedures or resection with primary anastomosis and protective stomas.

Trial Locations

Locations (1)

Azienda ospedaliera universitaria paolo giaccone; 🇮🇹 Palermo, Italy