Acute DiverticulitisSIGMA-DNCT06344078
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 of Acute Diverticulitis and Stoma Colostomy, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Acute Diverticulitis, Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- sigmoid resection and anastomosis / stoma
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: general population
Who may be able to join
- 18 yo or older
- CT scan and WSES classification
- surgical intervention within 48 hours for acute diverticulitis
Who cannot join
- underaged
- conservative treatment for acute diverticulitis
- other treatment
- diagnosis of colorectal cancer at histology
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda ospedaliera universitaria paolo giaccone
Palermo
francesco ferrara, medicine and surgery, +393343035829, frr.fra@gmail.com
claudio guerci, +393473898094, guerci.clau@gmail.com
About this study
Official title: 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.
- Conditions
- Acute Diverticulitis, Stoma Colostomy, Stoma Ileostomy
- Being tested
- sigmoid resection and anastomosis / stoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sigmoid resection and anastomosis / stomaProcedure or surgery
intestinal resection and recostruction or creation of stoma
| Study group | Role | What they receive |
|---|---|---|
| patients operated for acute diverticulitis | patient with acute diverticulitis which are operated in urgency setting Receives: Procedure: sigmoid resection and anastomosis / stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
adhesion to guidelines
assess whether Italian colorectal surgeons adhere to current guidelines, providing insights into the management of this disease.
Measured: 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.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Donato F Altomare, Societa Italiana di Chirurgia ColoRettale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344078
- Sponsor's protocol ID
- SIGMA-d
- Acronym
- SIGMA-D
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06344078
- Acronym / sponsor ID
- SIGMA-D / SIGMA-d
- Conditions
- Acute Diverticulitis, Stoma Colostomy, Stoma Ileostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients operated for acute diverticulitis | – | Procedure: sigmoid resection and anastomosis / stomapatient with acute diverticulitis which are operated in urgency setting |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (3 listed)
- 18 yo or older
- CT scan and WSES classification
- surgical intervention within 48 hours for acute diverticulitis
Key exclusion criteria (4 listed)
- underaged
- conservative treatment for acute diverticulitis
- other treatment
- diagnosis of colorectal cancer at histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sigmoid resection and anastomosis / stomaintestinal resection and recostruction or creation of stoma | Procedure or surgery | patients operated for acute diverticulitis |
Primary outcome
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 secondary outcome
stoma reversal
Time frame: 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis and Stoma Colostomy, run by Societa Italiana di Chirurgia ColoRettale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adhesion to guidelines (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.