Abdominal Free Air After Surgery

NCT ID: NCT01639170

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prediction of Gastrointestinal Perforation

Keywords

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Pneumoperitoneum Free air Surgery Perforation Radiograph

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

chest radiograph

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Francesco Milone

Prof. of Surgery. Director of the department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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"Federico II" University

Naples, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Milone, Prof

Role: CONTACT

Phone: 00390817463067

Email: [email protected]

Facility Contacts

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Francesco Milone, Prof.

Role: primary

References

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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.

Reference Type RESULT
PMID: 10950010 (View on PubMed)

Hope 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.

Reference Type RESULT
PMID: 19851274 (View on PubMed)

BRYANT 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.

Reference Type RESULT
PMID: 14048004 (View on PubMed)

Nielsen KT, Lund L, Larsen LP, Knudsen P. Duration of postoperative pneumoperitoneum. Eur J Surg. 1997 Jul;163(7):501-3.

Reference Type RESULT
PMID: 9248983 (View on PubMed)

Gayer 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.

Reference Type RESULT
PMID: 10823456 (View on PubMed)

Schauer 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.

Reference Type RESULT
PMID: 9012426 (View on PubMed)

Millitz 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.

Reference Type RESULT
PMID: 8092019 (View on PubMed)

Earls 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.

Reference Type RESULT
PMID: 8372757 (View on PubMed)

Milone 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.

Reference Type DERIVED
PMID: 23877326 (View on PubMed)

Other Identifiers

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Federico II-0919

Identifier Type: -

Identifier Source: org_study_id