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).

S

Societa Italiana di Chirurgia ColoRettale

Status

Enrolling

Conditions

Stoma Colostomy
Acute Diverticulitis
Stoma Ileostomy

Treatments

Procedure: sigmoid resection and anastomosis / stoma

Study type

Observational

Funder types

NETWORK

Identifiers

NCT06344078
SIGMA-d

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

patients operated for acute diverticulitis
Description:
patient with acute diverticulitis which are operated in urgency setting
Treatment:
Procedure: sigmoid resection and anastomosis / stoma

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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