(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Adhesive Small Intestine Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GG

Group Type EXPERIMENTAL

Gastrografin®: G

Intervention Type DRUG

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.

TT

Group Type OTHER

traditional conservative treatment (TT)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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water-soluble contrast medium (Gastrografin®: G) meal

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No