(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Study Overview
=================
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).

Official Title
-----------------
Gastrografin Use in Small Bowel Obstruction Caused by Adherences

Conditions
-----------------
Adhesive Small Intestine Obstruction

Intervention / Treatment
-----------------
* Other: traditional conservative treatment (TT)
* Drug: Gastrografin®: G


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GG<br> | Drug: Gastrografin®: G<br>* 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.<br>* Other names: water-soluble contrast medium (Gastrografin®: G) meal;|
| Other: TT<br> | Other: traditional conservative treatment (TT)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operative rate in ASIO patients |  | Within 72 hours and during hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal, Adhesive Small Intestine Obstruction, Oral water soluble contrast, Non-operative Conservative Management, Operative rate, Hospital stay