International Register of Open Abdomen

NCT ID: NCT02382770

Last Updated: 2017-01-27

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.

Detailed Description

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Conditions

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Open Abdomen Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open Abdomen patients

All patients underwent to open abdomen procedure

Open abdomen procedure

Intervention Type PROCEDURE

Patients who may need at the end of surgical procedure will be left with open abdomen dressed with different devices or dressing according to the institutional indications.

Interventions

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Open abdomen procedure

Patients who may need at the end of surgical procedure will be left with open abdomen dressed with different devices or dressing according to the institutional indications.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* No age limit
* Indication to Open Abdomen
* Informed consent

Exclusion Criteria

* Informed consent refusal
* No indication to Open Abdomen
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role lead

Responsible Party

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Federico Coccolini, MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Coccolini, MD

Role: PRINCIPAL_INVESTIGATOR

Papa Giovanni XXIII, P.zza OMS 1, 24128 Bergamo, Italy

Locations

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- Emergency and Trauma Surgery dept., Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Letterkenny Surgery dept. Letterkenny Hospital

Letterkenny, , Ireland

Site Status RECRUITING

Papa Giovanni XXIII hospital,

Bergamo, , Italy

Site Status RECRUITING

Emergency Surgery, Parma Universitary hospital

Parma, , Italy

Site Status RECRUITING

Countries

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United States Ireland Italy

Central Contacts

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Federico Coccolini, MD

Role: CONTACT

0039-0352673486

Facility Contacts

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James Whelan, MD

Role: primary

Michael Sugrue, MD

Role: primary

Federico Coccolini, MD

Role: primary

0035-2673486

Fausto Catena, MD

Role: primary

References

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Sibilla MG, Cremonini C, Portinari M, Carcoforo P, Tartaglia D, Cicuttin E, Musetti S, Strambi S, Sartelli M, Radica MK, Catena F, Chiarugi M, Coccolini F; IROA Study Group. Patients with an Open Abdomen in Asian, American and European Continents: A Comparative Analysis from the International Register of Open Abdomen (IROA). World J Surg. 2023 Jan;47(1):142-151. doi: 10.1007/s00268-022-06733-4. Epub 2022 Nov 3.

Reference Type DERIVED
PMID: 36326921 (View on PubMed)

Coccolini F, Gubbiotti F, Ceresoli M, Tartaglia D, Fugazzola P, Ansaloni L, Sartelli M, Kluger Y, Kirkpatrick A, Amico F, Catena F, Chiarugi M; IROA study group. Open Abdomen and Fluid Instillation in the Septic Abdomen: Results from the IROA Study. World J Surg. 2020 Dec;44(12):4032-4040. doi: 10.1007/s00268-020-05728-3. Epub 2020 Aug 24.

Reference Type DERIVED
PMID: 32833107 (View on PubMed)

Ceresoli M, Salvetti F, Kluger Y, Braga M, Vigano J, Fugazzola P, Sartelli M, Ansaloni L, Catena F, Coccolini F; IROA study group. Open Abdomen in Obese Patients: Pay Attention! New Evidences from IROA, the International Register of Open Abdomen. World J Surg. 2020 Jan;44(1):53-62. doi: 10.1007/s00268-019-05209-2.

Reference Type DERIVED
PMID: 31602518 (View on PubMed)

Coccolini F, Montori G, Ceresoli M, Catena F, Ivatury R, Sugrue M, Sartelli M, Fugazzola P, Corbella D, Salvetti F, Negoi I, Zese M, Occhionorelli S, Maccatrozzo S, Shlyapnikov S, Galatioto C, Chiarugi M, Demetrashvili Z, Dondossola D, Yovtchev Y, Ioannidis O, Novelli G, Nacoti M, Khor D, Inaba K, Demetriades D, Kaussen T, Jusoh AC, Ghannam W, Sakakushev B, Guetta O, Dogjani A, Costa S, Singh S, Damaskos D, Isik A, Yuan KC, Trotta F, Rausei S, Martinez-Perez A, Bellanova G, Fonseca VC, Hernandez F, Marinis A, Fernandes W, Quiodettis M, Bala M, Vereczkei A, Curado RL, Fraga GP, Pereira BM, Gachabayov M, Chagerben GP, Arellano ML, Ozyazici S, Costa G, Tezcaner T, Ansaloni L. IROA: International Register of Open Abdomen, preliminary results. World J Emerg Surg. 2017 Feb 21;12:10. doi: 10.1186/s13017-017-0123-8. eCollection 2017.

Reference Type DERIVED
PMID: 28239409 (View on PubMed)

Coccolini F, Catena F, Montori G, Ceresoli M, Manfredi R, Nita GE, Moore EE, Biffl W, Ivatury R, Whelan J, Fraga G, Leppaniemi A, Sartelli M, Di Saverio S, Ansaloni L. IROA: the International Register of Open Abdomen.: An international effort to better understand the open abdomen: call for participants. World J Emerg Surg. 2015 Aug 16;10:37. doi: 10.1186/s13017-015-0029-2. eCollection 2015.

Reference Type DERIVED
PMID: 26279673 (View on PubMed)

Other Identifiers

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15-15

Identifier Type: -

Identifier Source: org_study_id

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