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

This study has been completed.
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00601809
First received: January 14, 2008
Last updated: January 25, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Adhesive Small Intestine Obstruction
 Other: traditional conservative treatment (TT)
Drug: Gastrografin®: G
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • The operative rate in ASIO patients [ Time Frame: Within 72 hours and during hospital stay ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence of major and minor complications of treatments in the two arm [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The ASIO recurrences [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The time to resolution of obstruction [ Time Frame: Within hospital stay ] [ Designated as safety issue: No ]
  • The length of hospital stay [ Time Frame: Within hospital admission period ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: September 2003
Study Completion Date: November 2006
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601809

Locations
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
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

No publications provided by University of Bologna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Fausto Catena M.D. PhD, S. Orsola Malpighi University Hospital - University of Bologna
ClinicalTrials.gov Identifier: NCT00601809     History of Changes
Other Study ID Numbers: GUSBOCA
Study First Received: January 14, 2008
Last Updated: January 25, 2008
Health Authority: Italy: Ethics Committee

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:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013