Abdominal Free Air After Surgery

July 16, 2012 updated by: Francesco Milone, Federico II University

Intra-abdominal Free Air on a Plain Radiograph After Surgery. Could it be a Finding That May Predict Gastrointestinal Perforation?

The aim of this study is to evaluate if the presence of abdominal free air on a plain chest radiograph predicts gastrointestinal perforation. We aimed to enroll all patients undergoing abdominal surgery reporting major symptoms and signs suggestive of gastrointestinal perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • "Federico II" University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Abdominal surgery and major symptoms and signs suggestive of gastrointestinal perforation within the third postoperative day.

Exclusion Criteria:

  • inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subjects undergoing abdominal surgery

Subjects who undergone abdominal intervention and reported major symptoms and signs suggestive of gastrointestinal perforation (abdominal pain, leukocytosis, fever) within the third postoperative day.

Exclusion criteria: inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.
Radiation: chest radiograph

All enrolled patients underwent erect chest x-rays assessment. In all cases the diagnosis of pneumoperitoneum was based upon the plain film identification of subdiaphragmatic air on the upright posteroanterior chest radiograph.

All patients were transported from their hospital rooms to the radiology department in wheelchairs and remained in an upright position for more than 10 min before the chest radiographs were obtained. In all cases upright posteroanterior was obtained with the patient standing, using 183-cm distance, 125 kVp, phototimed exposure, and radiographic film with a wide exposure latitude.

The disappearance of intraabdominal free gas will be evaluated every 48h and will be defined as the loss of the

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prediction of gastrointestinal perforation
Time Frame: Within 3 days from surgery
• Prediction of the presence of gastrointestinal perforation by the finding of intra-abdominal free air on a chest radiograph after abdominal surgery
Within 3 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time taken for the absorption of intra-abdominal free air
Time Frame: within 3 days from surgery

The evaluation of time taken for the absorption of intra-abominal free air and its correlation with age, sex, body mass index, previous surgery, operative time, type of surgery and use of peritoneal drainage tubes.

The disappearance of intra-abdominal free gas was defined as the loss of the gas bubble under the domes of the hemidiaphragms on an erect chest radiograph
within 3 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Federico II-0919

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prediction of Gastrointestinal Perforation

Clinical Trials on chest radiograph

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe