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(Gastrografin Use in Small Bowel Obstruction Caused by Adherences) (GUSBOCA)

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ClinicalTrials.gov Identifier: NCT00601809
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 28, 2008
Sponsor:
Information provided by:
University of Bologna

Study Description
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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).


Condition or disease Intervention/treatment Phase
Adhesive Small Intestine Obstruction Other: traditional conservative treatment (TT) Drug: Gastrografin®: G Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastrografin Use in Small Bowel Obstruction Caused by Adherences
Study Start Date : September 2003
Actual Study Completion Date : November 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GG 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. The operative rate in ASIO patients [ Time Frame: Within 72 hours and during hospital stay ]

Secondary Outcome Measures :
  1. The incidence of major and minor complications of treatments in the two arm [ Time Frame: 1 year ]
  2. The ASIO recurrences [ Time Frame: 1 year ]
  3. The time to resolution of obstruction [ Time Frame: Within hospital stay ]
  4. The length of hospital stay [ Time Frame: Within hospital admission period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601809


Locations
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Italy
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna, Italy
Emergency Surgery Department - University of Modena
Modena, Italy
Sponsors and Collaborators
University of Bologna
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Fausto Catena M.D. PhD, S. Orsola Malpighi University Hospital - University of Bologna
ClinicalTrials.gov Identifier: NCT00601809    
Other Study ID Numbers: GUSBOCA
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2008
Keywords provided by University of Bologna:
Gastrointestinal
Adhesive Small Intestine Obstruction
Oral water soluble contrast
 Non-operative Conservative Management
Operative rate
Hospital stay
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases