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). (SIGMA-D)

March 27, 2024 updated by: Donato F Altomare, Societa Italiana di Chirurgia ColoRettale

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Paolo Giaccone
        • Contact:
          • francesco ferrara, medicine and surgery
          • Phone Number: +393343035829
          • Email: frr.fra@gmail.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

general population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients operated for acute diverticulitis
patient with acute diverticulitis which are operated in urgency setting
Procedure: sigmoid resection and anastomosis / stoma
intestinal resection and recostruction or creation of stoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adhesion to guidelines
Time Frame: 1 year follow-up
assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stoma reversal
Time Frame: 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.
1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana di Chirurgia ColoRettale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGMA-d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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