Abdominal Free Air After Surgery

NCT01639170 | Unknown

• 1 other identifier: Federico II-0919
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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) within the third postoperative day.

Conditions

Prediction of Gastrointestinal Perforation

Keywords

Pneumoperitoneum; Free air; Surgery; Perforation; Radiograph

Outcome Measures

Primary Outcomes (1)

• 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

  Within 3 days from surgery

Secondary Outcomes (1)

• time taken for the absorption of intra-abdominal free air

  within 3 days from surgery

Study Arms (1)

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.

Radiation: chest radiograph

Interventions

chest radiograph 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

subjects undergoing abdominal surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

"Federico II" University

Naples, Italy, 80131, Italy

RECRUITING

Related Publications (9)

• 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.

  PMID: 10950010 RESULT

• 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.

  PMID: 19851274 RESULT

• 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.

  PMID: 14048004 RESULT

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

  PMID: 9248983 RESULT

• 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.

  PMID: 10823456 RESULT

• 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.

  PMID: 9012426 RESULT

• 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.

  PMID: 8092019 RESULT

• 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.

  PMID: 8372757 RESULT

• 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.

  PMID: 23877326 DERIVED

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Central Study Contacts

Francesco Milone, Prof

CONTACT

00390817463067; milone.marco@alice.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Surgery. Director of the department

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-06

Locations

IT (1)