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Sponsored by: |
University of Bologna |
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Information provided by: | University of Bologna |
ClinicalTrials.gov Identifier: | NCT00601809 |
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).
Condition | Intervention | Phase |
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Adhesive Small Intestine Obstruction |
Other: traditional conservative treatment (TT) Drug: Gastrografin®: G |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Gastrografin Use in Small Bowel Obstruction Caused by Adherences |
Enrollment: | 76 |
Study Start Date: | September 2003 |
Study Completion Date: | November 2006 |
Arms | Assigned Interventions |
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GG: Experimental |
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.
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TT |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
S.Orsola-Malpighi University Hospital - University of Bologna | |
BOLOGNA, Italy | |
Emergency Surgery Department - University of Modena | |
Modena, Italy |
Principal Investigator: | Fausto Catena, MD, PhD | S.Orsola-Malpighi University Hospital - University of Bologna |
Principal Investigator: | Luca Ansaloni, MD | S.Orsola-Malpighi University Hospital - University of Bologna |
Principal Investigator: | Margherita Gavioli, MD | University of Modena |
Principal Investigator: | Salomone Di Saverio, M.D. | S.Orsola-Malpighi University Hospital - University of Bologna |
Responsible Party: | S. Orsola Malpighi University Hospital - University of Bologna ( Dr. Fausto Catena M.D. PhD ) |
Study ID Numbers: | GUSBOCA |
Study First Received: | January 14, 2008 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00601809 History of Changes |
Health Authority: | Italy: Ethics Committee |
Gastrointestinal Adhesive Small Intestine Obstruction Oral water soluble contrast |
Non-operative Conservative Management Operative rate Hospital stay |
Intestinal Obstruction Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Intestinal Obstruction Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |