Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-01-31

Brief Summary

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Mini abstract :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.

Detailed Description

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Abstract

Background:

Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.

Patients and methods :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.

Conditions

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Small Bowel Obstruction

Keywords

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Adhesions Oral contrast Exploration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Gastrografin group

Group Type ACTIVE_COMPARATOR

Oral Gastrografin

Intervention Type OTHER

100 ml of the dye administered through a nasogastric tube

2

Control group

Group Type PLACEBO_COMPARATOR

Nothing per os

Intervention Type OTHER

A nasogastric tube

Interventions

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Oral Gastrografin

100 ml of the dye administered through a nasogastric tube

Intervention Type OTHER

Nothing per os

A nasogastric tube

Intervention Type OTHER

Other Intervention Names

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oral contrast no oral contrast

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.

Exclusion Criteria

* Age less than 18 years
* Large bowel obstruction
* Recent (within 4 weeks) abdominal surgery
* Ileus
* Cancer peritonitis
* Peritonitis
* Strangulation symptoms and signs
* Obstructed abdominal wall or groin hernia
* Subtotal or total colectomy
* All patients in whom the final diagnosis was not SBO

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Mansoura University

Principal Investigators

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amir fikry, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

ayman mohamed, MD

Role: STUDY_DIRECTOR

Mansoura University Hospital

Locations

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Mansoura University Hospital

Al Mansurah, , Egypt

Site Status

Countries

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Egypt