Clinical trial NCT00601809: (Gastrografin Use in Small Bowel Obstruction Caused by Adherences)
Official title: Gastrografin Use in Small Bowel Obstruction Caused by Adherences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesive Small Intestine Obstruction
Keywords: Gastrointestinal
Adhesive Small Intestine Obstruction
Oral water soluble contrast
Non-operative Conservative Management
Operative rate
Hospital stay
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: The operative rate in ASIO patients
timeFrame: Within 72 hours and during hospital stay
Secondary outcomes:
measure: The incidence of major and minor complications of treatments in the two arm
timeFrame: 1 year
measure: The ASIO recurrences
timeFrame: 1 year
measure: The time to resolution of obstruction
timeFrame: Within hospital stay
measure: The length of hospital stay
timeFrame: Within hospital admission period
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S.Orsola-Malpighi University Hospital - University of Bologna
city: Modena
country: Italy
facility: Emergency Surgery Department - University of Modena
Study officials:
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Fausto Catena, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Luca Ansaloni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Modena
name: Margherita Gavioli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
name: Salomone Di Saverio, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s00268-008-9694-6.