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CompletedNCT00738855Updated Nov 26, 2008

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

An interventional study of Oral Gastrografin and Nothing per os in Small Bowel Obstruction, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-11-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Small Bowel Obstruction

Keywords

  • Adhesions
  • Oral contrast
  • Exploration
03

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 80 interventional studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    1

    Gastrografin group

    Other: Oral Gastrografin

  • Placebo comparator
    2

    Control group

    Other: Nothing per os

Interventions

  • OtherOral Gastrografin

    100 ml of the dye administered through a nasogastric tube

    Also known as: oral contrast

  • OtherNothing per os

    A nasogastric tube

    Also known as: no oral contrast

06

What researchers measure

Primary outcomes

  1. resolving

    Time frame: 48 hours

Secondary outcomes

  1. non resolving

    Time frame: 48 hours

07

Study locations

1 site
  • Mansoura University Hospital
    Mansoura, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00738855
Lead sponsor
Mansoura University
First posted
Aug 21, 2008
Start date
Feb 2006
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Nov 26, 2008

Study contacts

amir fikry, MD
principal investigator · Mansoura University Hospital
ayman mohamed, MD
study director · Mansoura University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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