(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Condition(s) targeted: Adhesive Small Intestine Obstruction

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

Phase: Phase 4

Status: Completed

Sponsored by: University of Bologna

Official(s) and/or principal investigator(s):
Fausto Catena, MD, PhD, Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Luca Ansaloni, MD, Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna
Margherita Gavioli, MD, Principal Investigator, Affiliation: University of Modena
Salomone Di Saverio, M.D., Principal Investigator, Affiliation: S.Orsola-Malpighi University Hospital - University of Bologna

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).

Official title: Gastrografin Use in Small Bowel Obstruction Caused by Adherences

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

Primary outcome: The operative rate in ASIO patients

Secondary outcome:

The incidence of major and minor complications of treatments in the two arm

The ASIO recurrences

The time to resolution of obstruction

The length of hospital stay

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

S.Orsola-Malpighi University Hospital - University of Bologna, BOLOGNA, Italy

Emergency Surgery Department - University of Modena, Modena, Italy

Starting date: September 2003
Ending date: November 2006
Last updated: January 25, 2008