(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) (GUSBOCA)

University of Bologna

Status and phase: Completed; Phase 4

Conditions: Adhesive Small Intestine Obstruction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00601809

GUSBOCA

Details and patient eligibility

About

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).

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

GG

Experimental group

Treatment:

Drug: Gastrografin®: G

TT

Other group

Treatment:

Other: traditional conservative treatment (TT)