Prediction of Gastrointestinal PerforationNCT01639170
Abdominal Free Air After Surgery
A study testing chest radiograph in people with Prediction of Gastrointestinal Perforation, run by Federico II University at 1 site in Italy.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prediction of Gastrointestinal Perforation
- What is being tested?
- chest radiograph
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal surgery and major symptoms and signs suggestive of gastrointestinal perforation within the third postoperative day.
Who cannot join
- inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Federico II" University
Naples, Italy, 80131
Francesco Milone, Prof., 00390817463067, milone.marco@alice.it
About this study
Official title: 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.
- Being tested
- chest radiograph
- Keywords
- Pneumoperitoneum, Free air, Surgery, Perforation, Radiograph
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest radiographRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| subjects undergoing abdominal surgery | Experimental | 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. Receives: Radiation: chest radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
prediction of gastrointestinal perforation
- Prediction of the presence of gastrointestinal perforation by the finding of intra-abdominal free air on a chest radiograph after abdominal surgery
Measured: Within 3 days from surgery
Secondary outcomes (1)
time taken for the absorption of intra-abdominal free air
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
Measured: within 3 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Prediction of Gastrointestinal PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Milone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639170
- Sponsor's protocol ID
- Federico II-0919
- Status last verified
- Jun 2012
- First submitted
- 10 Jul 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
Publications
Tang CL, Yeong KY, Nyam DC, Eu KW, Ho YH, Leong AF, Tsang CB, Seow-Choen F. Postoperative intra-abdominal free gas after open colorectal resection. Dis Colon Rectum. 2000 Aug;43(8):1116-20. doi: 10.1007/BF02236559.
PubMed 10950010Hope WW, Heniford BT, Norton HJ, Lincourt AE, Teigland CM, Kercher KW. Duration and clinical significance of radiographically detected "free air" after laparoscopic nephrectomy. Surg Laparosc Endosc Percutan Tech. 2009 Oct;19(5):415-8. doi: 10.1097/SLE.0b013e3181b6bff3.
PubMed 19851274BRYANT LR, WIOT JF, KLOECKER RJ. A STUDY OF THE FACTORS AFFECTING THE INCIDENCE AND DURATION OF POSTOPERATIVE PNEUMOPERITONEUM. Surg Gynecol Obstet. 1963 Aug;117:145-50. No abstract available.
PubMed 14048004Nielsen KT, Lund L, Larsen LP, Knudsen P. Duration of postoperative pneumoperitoneum. Eur J Surg. 1997 Jul;163(7):501-3.
PubMed 9248983Gayer G, Jonas T, Apter S, Amitai M, Shabtai M, Hertz M. Postoperative pneumoperitoneum as detected by CT: prevalence, duration, and relevant factors affecting its possible significance. Abdom Imaging. 2000 May-Jun;25(3):301-5. doi: 10.1007/s002610000036.
PubMed 10823456Schauer PR, Page CP, Ghiatas AA, Miller JE, Schwesinger WH, Sirinek KR. Incidence and significance of subdiaphragmatic air following laparoscopic cholecystectomy. Am Surg. 1997 Feb;63(2):132-6.
PubMed 9012426Millitz K, Moote DJ, Sparrow RK, Girotti MJ, Holliday RL, McLarty TD. Pneumoperitoneum after laparoscopic cholecystectomy: frequency and duration as seen on upright chest radiographs. AJR Am J Roentgenol. 1994 Oct;163(4):837-9. doi: 10.2214/ajr.163.4.8092019.
PubMed 8092019Earls JP, Dachman AH, Colon E, Garrett MG, Molloy M. Prevalence and duration of postoperative pneumoperitoneum: sensitivity of CT vs left lateral decubitus radiography. AJR Am J Roentgenol. 1993 Oct;161(4):781-5. doi: 10.2214/ajr.161.4.8372757.
PubMed 8372757Milone M, Di Minno MN, Bifulco G, Maietta P, Sosa Fernandez LM, Musella M, Iaccarino V, Buccelli C, Nappi C, Milone F. Diagnostic value of abdominal free air detection on a plain chest radiograph in the early postoperative period: a prospective study in 648 consecutive patients who have undergone abdominal surgery. J Gastrointest Surg. 2013 Sep;17(9):1673-82. doi: 10.1007/s11605-013-2282-6. Epub 2013 Jul 20.
PubMed 23877326
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-abdominal Free Air on a Plain Radiograph After Surgery. Could it be a Finding That May Predict Gastrointestinal Perforation?
- ClinicalTrials.gov ID
- NCT01639170
- Acronym / sponsor ID
- Federico II-0919
- Keywords
- Pneumoperitoneum, Free air, Surgery, Perforation, Radiograph
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects undergoing abdominal surgery | Experimental | Radiation: chest radiographSubjects 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abdominal surgery and major symptoms and signs suggestive of gastrointestinal perforation within the third postoperative day.
Key exclusion criteria (1 listed)
- inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest radiographAll 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 | Radiation | subjects undergoing abdominal surgery |
Primary outcome
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
1 secondary outcome
time taken for the absorption of intra-abdominal free air
Time frame: within 3 days from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Results publication: PubMed 10950010Tang CL, Yeong KY, Nyam DC, Eu KW, Ho YH, Leong AF, Tsang CB, Seow-Choen F. Postoperative intra-abdominal free gas after open colorectal resection. Dis Colon Rectum. 2000 Aug;43(8):1116-20. doi: 10.1007/BF02236559.
- Results publication: PubMed 19851274Hope WW, Heniford BT, Norton HJ, Lincourt AE, Teigland CM, Kercher KW. Duration and clinical significance of radiographically detected "free air" after laparoscopic nephrectomy. Surg Laparosc Endosc Percutan Tech. 2009 Oct;19(5):415-8. doi: 10.1097/SLE.0b013e3181b6bff3.
- Results publication: PubMed 14048004BRYANT LR, WIOT JF, KLOECKER RJ. A STUDY OF THE FACTORS AFFECTING THE INCIDENCE AND DURATION OF POSTOPERATIVE PNEUMOPERITONEUM. Surg Gynecol Obstet. 1963 Aug;117:145-50. No abstract available.
- Results publication: PubMed 9248983Nielsen KT, Lund L, Larsen LP, Knudsen P. Duration of postoperative pneumoperitoneum. Eur J Surg. 1997 Jul;163(7):501-3.
- Results publication: PubMed 10823456Gayer G, Jonas T, Apter S, Amitai M, Shabtai M, Hertz M. Postoperative pneumoperitoneum as detected by CT: prevalence, duration, and relevant factors affecting its possible significance. Abdom Imaging. 2000 May-Jun;25(3):301-5. doi: 10.1007/s002610000036.
- Results publication: PubMed 9012426Schauer PR, Page CP, Ghiatas AA, Miller JE, Schwesinger WH, Sirinek KR. Incidence and significance of subdiaphragmatic air following laparoscopic cholecystectomy. Am Surg. 1997 Feb;63(2):132-6.
- Results publication: PubMed 8092019Millitz K, Moote DJ, Sparrow RK, Girotti MJ, Holliday RL, McLarty TD. Pneumoperitoneum after laparoscopic cholecystectomy: frequency and duration as seen on upright chest radiographs. AJR Am J Roentgenol. 1994 Oct;163(4):837-9. doi: 10.2214/ajr.163.4.8092019.
- Results publication: PubMed 8372757Earls JP, Dachman AH, Colon E, Garrett MG, Molloy M. Prevalence and duration of postoperative pneumoperitoneum: sensitivity of CT vs left lateral decubitus radiography. AJR Am J Roentgenol. 1993 Oct;161(4):781-5. doi: 10.2214/ajr.161.4.8372757.
- Derived from this study: PubMed 23877326Milone M, Di Minno MN, Bifulco G, Maietta P, Sosa Fernandez LM, Musella M, Iaccarino V, Buccelli C, Nappi C, Milone F. Diagnostic value of abdominal free air detection on a plain chest radiograph in the early postoperative period: a prospective study in 648 consecutive patients who have undergone abdominal surgery. J Gastrointest Surg. 2013 Sep;17(9):1673-82. doi: 10.1007/s11605-013-2282-6. Epub 2013 Jul 20.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest radiograph in people with Prediction of Gastrointestinal Perforation, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Milone, Prof (00390817463067, milone.marco@alice.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of gastrointestinal perforation (time frame: Within 3 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01639170, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.