(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Adhesive Small Intestine Obstruction Clinical Trial

— GUSBOCA  

Official title:

Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601809
• Other study ID #: GUSBOCA
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: January 25, 2008
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: January 2008
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Small Intestine Obstruction
• Intestinal Obstruction

Intervention

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.

Locations

Country	Name	City	State
Italy	S.Orsola-Malpighi University Hospital - University of Bologna	Bologna
Italy	Emergency Surgery Department - University of Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The operative rate in ASIO patients		Within 72 hours and during hospital stay	Yes
Secondary	The incidence of major and minor complications of treatments in the two arm		1 year	Yes
Secondary	The ASIO recurrences		1 year	No
Secondary	The time to resolution of obstruction		Within hospital stay	No
Secondary	The length of hospital stay		Within hospital admission period	No