(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Phase 4

Completed

• Conditions: Adhesive Small Intestine Obstruction
• Interventions: Other: traditional conservative treatment (TT)

• Registration Number: NCT00601809
• Lead Sponsor: University of Bologna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2006-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-25
• Last Update Submitted: 2008-01-25
• Study First Posted: 2008-01-28
• Last Update Posted: 2008-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TT	traditional conservative treatment (TT)	-

Primary Outcome Measures

Name	Time	Method
The operative rate in ASIO patients	Within 72 hours and during hospital stay

Secondary Outcome Measures

Name	Time	Method
The incidence of major and minor complications of treatments in the two arm	1 year
The ASIO recurrences	1 year
The time to resolution of obstruction	Within hospital stay
The length of hospital stay	Within hospital admission period

Trial Locations

Locations (2)

S.Orsola-Malpighi University Hospital - University of Bologna; 🇮🇹 Bologna, Italy

Emergency Surgery Department - University of Modena; 🇮🇹 Modena, Italy