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International Register of Open Abdomen (IROA)

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ClinicalTrials.gov Identifier: NCT02382770
Recruitment Status : Unknown
Verified January 2017 by Federico Coccolini, MD, A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Recruiting
First Posted : March 9, 2015
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Federico Coccolini, MD, A.O. Ospedale Papa Giovanni XXIII

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.

Condition or disease Intervention/treatment
Open Abdomen Procedure Procedure: Open abdomen procedure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: International Register of Open Abdomen
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Open Abdomen patients
All patients underwent to open abdomen procedure
Procedure: 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.




Primary Outcome Measures :
  1. Indications to open abdomen [ Time Frame: Enrollment ]
  2. Techniques to perform open abdomen [ Time Frame: Enrollment ]
  3. Management of open abdomen [ Time Frame: Visit 2 ]
  4. Definitive closure techniques [ Time Frame: Visit 4 ]

Secondary Outcome Measures :
  1. Mortality rates linked to different techniques of open abdomen [ Time Frame: During All study period ]
  2. Morbidity rates linked to different techniques of open abdomen [ Time Frame: During All study period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who may require to be undergone to open abdomen procedure
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Informed consent refusal
  • No indication to Open Abdomen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382770


Contacts
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Contact: Federico Coccolini, MD 0039-0352673486 federico.coccolini@gmail.com

Locations
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United States, Virginia
- Emergency and Trauma Surgery dept., Virginia Commonwealth University Recruiting
Richmond, Virginia, United States
Contact: James Whelan, MD       jameswhelanmd@yahoo.com   
Ireland
Letterkenny Surgery dept. Letterkenny Hospital Recruiting
Letterkenny, Ireland
Contact: Michael Sugrue, MD       michael.sugrue@hse.ie   
Italy
Papa Giovanni XXIII hospital, Recruiting
Bergamo, Italy, 24128
Contact: Federico Coccolini, MD    0035-2673486    federico.coccolini@gmail.com   
Emergency Surgery, Parma Universitary hospital Recruiting
Parma, Italy
Contact: Fausto Catena, MD       faustocatena@gmail.com   
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
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Principal Investigator: Federico Coccolini, MD Papa Giovanni XXIII, P.zza OMS 1, 24128 Bergamo, Italy
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Hernández 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. Erratum in: World J Emerg Surg. 2017 Mar 9;12 :13.

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Responsible Party: Federico Coccolini, MD, M.D., A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT02382770    
Other Study ID Numbers: 15-15
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017