Clinical trial NCT02382770: International Register of Open Abdomen
Official title: International Register of Open Abdomen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Open Abdomen Procedure
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who may require to be undergone to open abdomen procedure

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Informed consent refusal
* No indication to Open Abdomen

Primary outcomes:
measure: Indications to open abdomen
timeFrame: Enrollment
measure: Techniques to perform open abdomen
timeFrame: Enrollment
measure: Management of open abdomen
timeFrame: Visit 2
measure: Definitive closure techniques
timeFrame: Visit 4
Secondary outcomes:
measure: Mortality rates linked to different techniques of open abdomen
timeFrame: During All study period
measure: Morbidity rates linked to different techniques of open abdomen
timeFrame: During All study period
Other outcomes:
Locations:
city: Richmond
country: United States
facility: - Emergency and Trauma Surgery dept., Virginia Commonwealth University
state: Virginia
city: Letterkenny
country: Ireland
facility: Letterkenny Surgery dept. Letterkenny Hospital
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII hospital,
city: Parma
country: Italy
facility: Emergency Surgery, Parma Universitary hospital
Study officials:
affiliation: Papa Giovanni XXIII, P.zza OMS 1, 24128 Bergamo, Italy
name: Federico Coccolini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.