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).

NCT ID: NCT06344078

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Diverticulitis Stoma Colostomy Stoma Ileostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients operated for acute diverticulitis

patient with acute diverticulitis which are operated in urgency setting

sigmoid resection and anastomosis / stoma

Intervention Type PROCEDURE

intestinal resection and recostruction or creation of stoma

Interventions

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sigmoid resection and anastomosis / stoma

intestinal resection and recostruction or creation of stoma

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role lead

Responsible Party

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Donato F Altomare

DR FERRARA FRANCESCO

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda ospedaliera universitaria paolo giaccone

Palermo, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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francesco ferrara, medicine and surgery

Role: primary

+393343035829

claudio guerci

Role: backup

+393473898094

Other Identifiers

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SIGMA-d

Identifier Type: -

Identifier Source: org_study_id

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