(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) (GUSBOCA)
|ClinicalTrials.gov Identifier: NCT00601809|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 28, 2008
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 or disease||Intervention/treatment||Phase|
|Adhesive Small Intestine Obstruction||Other: traditional conservative treatment (TT) Drug: Gastrografin®: G||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gastrografin Use in Small Bowel Obstruction Caused by Adherences|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||November 2006|
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.
Other Name: water-soluble contrast medium (Gastrografin®: G) meal
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.
- The operative rate in ASIO patients [ Time Frame: Within 72 hours and during hospital stay ]
- The incidence of major and minor complications of treatments in the two arm [ Time Frame: 1 year ]
- The ASIO recurrences [ Time Frame: 1 year ]
- The time to resolution of obstruction [ Time Frame: Within hospital stay ]
- The length of hospital stay [ Time Frame: Within hospital admission period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601809
|S.Orsola-Malpighi University Hospital - University of Bologna|
|Emergency Surgery Department - University of Modena|
|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|