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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).

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).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06344078
Acronym
SIGMA-D
Enrollment
500
Registered
2024-04-03
Start date
2024-01-01
Completion date
2025-12-31
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diverticulitis, Stoma Colostomy, Stoma Ileostomy

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.

Interventions

PROCEDUREsigmoid resection and anastomosis / stoma

intestinal resection and recostruction or creation of stoma

Sponsors

Societa Italiana di Chirurgia ColoRettale
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
adhesion to guidelines1 year follow-upassess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.

Secondary

MeasureTime frameDescription
stoma reversal1 year follow-upunderstanding of the management of patients with stomas resulting from Hartmann's procedures or resection with primary anastomosis and protective stomas.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026