NCT00738855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
Last Updated

November 26, 2008

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

August 19, 2008

Last Update Submit

November 25, 2008

Conditions

Small Bowel Obstruction

Keywords

AdhesionsOral contrastExploration

Outcome Measures

Primary Outcomes (1)

  • resolving

    48 hours

Secondary Outcomes (1)

  • non resolving

    48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

Gastrografin group

Other: Oral Gastrografin

2

PLACEBO COMPARATOR

Control group

Other: Nothing per os

Interventions

Oral GastrografinOTHER

100 ml of the dye administered through a nasogastric tube

Also known as: oral contrast
1
Nothing per osOTHER

A nasogastric tube

Also known as: no oral contrast
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Tissue Adhesions

Interventions

Diatrizoate MeglumineContrast Media

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsDiatrizoateTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydratesDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • amir fikry, MD

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

  • ayman mohamed, MD

    Mansoura University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

February 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-08

Locations

EG(1)