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(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

NCT00601809 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2008-01-28

No results posted yet for this study

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).

Conditions

  • Adhesive Small Intestine Obstruction

Interventions

OTHER

traditional 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.

DRUG

Gastrografin®: 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 & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Fausto Catena, MD, PhD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Luca Ansaloni, MD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Margherita Gavioli, MD · University of Modena

  • Salomone Di Saverio, M.D. · S.Orsola-Malpighi University Hospital - University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2006-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00601809 on ClinicalTrials.gov