Recruiting

Observational Study

Sponsor:

A.O. Ospedale Papa Giovanni XXIII

Code:

NCT02382770

Conditions

Open Abdomen Procedure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Open abdomen procedure

Study Details

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.

Conditions

Open Abdomen Procedure

Study ID

NCT02382770

Start date

Feb, 2015

Status verified date

Jan, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Informed consent refusal
  • No indication to Open Abdomen

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Open Abdomen patients

All patients underwent to open abdomen procedure

Interventions

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 measure

  • Indications to open abdomen [ Time Frame: Enrollment ]
  • Techniques to perform open abdomen [ Time Frame: Enrollment ]
  • Management of open abdomen [ Time Frame: Visit 2 ]
  • Definitive closure techniques [ Time Frame: Visit 4 ]

Central Contacts and Locations

Central contacts

Federico Coccolini, MD

0039-0352673486federico.coccolini@gmail.com

Locations

- Emergency and Trauma Surgery dept., Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States

Contacts

James Whelan, MD

jameswhelanmd@yahoo.com

More Information

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Last update posted

Jan 27, 2017

Last verified

Jan, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by A.O. Ospedale Papa Giovanni XXIII on 2017-01-27.