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).

NCT06344078 | Recruiting

• 1 other identifier: SIGMA-d
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis; Stoma Colostomy; Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• stoma reversal

  1 year follow-up

Study Arms (1)

patients operated for acute diverticulitis

patient with acute diverticulitis which are operated in urgency setting

Procedure: sigmoid resection and anastomosis / stoma

Interventions

sigmoid resection and anastomosis / stoma PROCEDURE

intestinal resection and recostruction or creation of stoma

patients operated for acute diverticulitis

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

general population

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead

Study Sites (1)

Azienda ospedaliera universitaria paolo giaccone

Palermo, Italy

RECRUITING

MeSH Terms

Interventions

Anastomosis, Surgical

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR FERRARA FRANCESCO

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

IT (1)