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).

Last updated: March 27, 2024
Sponsor: Societa Italiana di Chirurgia ColoRettale
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Treatment

sigmoid resection and anastomosis / stoma

Clinical Study ID

NCT06344078
SIGMA-d
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: sigmoid resection and anastomosis / stoma
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Azienda ospedaliera universitaria paolo giaccone

    Palermo,
    Italy

    Active - Recruiting

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