ClinicalTrials.gg
RecruitingNCT06344078SIGMA-DUpdated Apr 3, 2024

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).

An observational study in Acute Diverticulitis, Stoma Colostomy and Stoma Ileostomy, sponsored by Societa Italiana di Chirurgia ColoRettale. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Societa Italiana di Chirurgia ColoRettale · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 120 Years
Sex
All
01

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.

02

Conditions studied

  • Acute Diverticulitis
  • Stoma Colostomy
  • Stoma Ileostomy

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03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's planned enrollment of 500 is above the median of 275 across 59 observational studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Societa Italiana di Chirurgia ColoRettale is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

general population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • underaged
  • conservative treatment for acute diverticulitis
  • other treatment
  • diagnosis of colorectal cancer at histology
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients operated for acute diverticulitis

    patient with acute diverticulitis which are operated in urgency setting

    Procedure: sigmoid resection and anastomosis / stoma

Interventions

  • Proceduresigmoid resection and anastomosis / stoma

    intestinal resection and recostruction or creation of stoma

06

What researchers measure

Primary outcomes

  1. adhesion to guidelines

    assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.

    Time frame: 1 year follow-up

Secondary outcomes

  1. stoma reversal

    understanding of the management of patients with stomas resulting from Hartmann's procedures or resection with primary anastomosis and protective stomas.

    Time frame: 1 year follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2025, 23 months after the start.

Of 22 observational studies under Diverticulitis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 101. This study's planned 23 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
Apr 3, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06344078
Lead sponsor
Societa Italiana di Chirurgia ColoRettale
Responsible party
Donato F Altomare (DR FERRARA FRANCESCO, Societa Italiana di Chirurgia ColoRettale) — Principal investigator
First posted
Apr 3, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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