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(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00601809
Acronym
GUSBOCA
Enrollment
76
Registered
2008-01-28
Start date
2003-09-30
Completion date
2006-11-30
Last updated
2008-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Small Intestine Obstruction

Keywords

Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay

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).

Interventions

OTHERtraditional conservative treatment (TT)

In the control group (TT: Traditional Treatment), the patients have been treated as in our daily surgical practice of traditional conservative treatment for ASIO, consisting in nil per os diet, nasogastric tube (NGT) decompression and intravenous fluid resuscitation therapy with electrolytes imbalances correction.

DRUGGastrografin®: G

The study group (GG: Gastrografin Group) received, beyond the traditional conservative treatment for ASIO above mentioned, a G meal with a follow-through study immediately.

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
The operative rate in ASIO patientsWithin 72 hours and during hospital stay

Secondary

MeasureTime frame
The incidence of major and minor complications of treatments in the two arm1 year
The ASIO recurrences1 year
The time to resolution of obstructionWithin hospital stay
The length of hospital stayWithin hospital admission period

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026