Gastrografin Use in Small Bowel Obstruction Caused by Adherences
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- The operative rate in ASIO patients
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TT
Intervention: traditional conservative treatment (TT) (Other)
Outcomes
Primary Outcomes
The operative rate in ASIO patients
Time Frame: Within 72 hours and during hospital stay
Secondary Outcomes
- The incidence of major and minor complications of treatments in the two arm(1 year)
- The ASIO recurrences(1 year)
- The time to resolution of obstruction(Within hospital stay)
- The length of hospital stay(Within hospital admission period)