Abdominal Free Air After Surgery

Prediction of Gastrointestinal Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01639170
• Other study ID #: Federico II-0919
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2012
• Last updated: July 16, 2012
• Start date: June 2011

Study information

• Verified date: June 2012
• Source: Federico II University
• Contact: Francesco Milone, Prof
• Phone: 00390817463067
• Email: milone.marco[@]alice.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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) within the third postoperative day.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prediction of Gastrointestinal Perforation

Intervention

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

Locations

Country	Name	City	State
Italy	"Federico II" University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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.0b — View Citation

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. — View Citation

Nielsen KT, Lund L, Larsen LP, Knudsen P. Duration of postoperative pneumoperitoneum. Eur J Surg. 1997 Jul;163(7):501-3. Erratum in: Eur J Surg 1997 Nov;163(11):880. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	within 3 days from surgery	Yes