(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 14, 2008

Last Updated Date

January 25, 2008

Start Date ^†

September 2003

Current Primary Outcome Measures ^†

The operative rate in ASIO patients [ Time Frame: Within 72 hours and during hospital stay ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00601809 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

The incidence of major and minor complications of treatments in the two arm [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The ASIO recurrences [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The time to resolution of obstruction [ Time Frame: Within hospital stay ] [ Designated as safety issue: No ]
The length of hospital stay [ Time Frame: Within hospital admission period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Official Title ^†

Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Brief Summary

Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value. The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Adhesive Small Intestine Obstruction

Intervention ^†

Other: traditional conservative treatment (TT)
Drug: Gastrografin®: G

Study Arms / Comparison Groups

Publications *

Di Saverio S, Catena F, Ansaloni L, Gavioli M, Valentino M, Pinna AD. Water-soluble contrast medium (gastrografin) value in adhesive small intestine obstruction (ASIO): a prospective, randomized, controlled, clinical trial. World J Surg. 2008 Oct;32(10):2293-304.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Adult patients (>18 years)
History of previous abdominal surgical procedures
Clinical and radiological evidence of adhesive small intestine obstruction without signs of strangulation and peritonism
ASA I-III patients
Informed consent

Exclusion Criteria:

Suspicion of strangulation
Actual presence or high suspicion of intra-abdominal malignancy
Suspicion or history of peritoneal carcinomatosis
active inflammatory bowel disease
Positive history of radiotherapy on the abdominal region
Obstructed hernias

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00601809

Responsible Party

Dr. Fausto Catena M.D. PhD, S. Orsola Malpighi University Hospital - University of Bologna

Secondary IDs ^††

Study Sponsor ^†

University of Bologna

Collaborators ^††

Investigators ^†

Principal Investigator:	Fausto Catena, MD, PhD	S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator:	Luca Ansaloni, MD	S.Orsola-Malpighi University Hospital - University of Bologna
Principal Investigator:	Margherita Gavioli, MD	University of Modena
Principal Investigator:	Salomone Di Saverio, M.D.	S.Orsola-Malpighi University Hospital - University of Bologna

Information Provided By

University of Bologna

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.