NCT01648972

Brief Summary

After abdominal surgery there is a period of unavoidable dysfunction of the gut. During this time patients are often unable to eat and drink, and do not pass any flatus or stool. Though this resolves within a few days for most, there are a significant number (around 30%) who go on to have a prolonged period of this dysfunction known clinically as postoperative ileus. It has been clearly shown that this group of patients have worse health outcomes and spend a longer time in hospital. The aim of this study is to trial a drug - gastrografin - in the management of prolonged postoperative ileus. Gastrografin is safe, economical, readily available, and has been used with great success in the similar condition of bowel obstruction. It is predicted that gastrografin will shorten the duration of a prolonged postoperative ileus, thus affording affected patients a better outcome from surgery.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2012

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

First Submitted

Initial submission to the registry

July 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

July 24, 2012

Last Update Submit

July 2, 2014

Conditions

Prolonged Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • Time from diagnosis (and administration of study drug) to resolution of prolonged postoperative ileus.

Secondary Outcomes (1)

  • Length of hospital stay (days)

    Days

Study Arms (2)

Gastrografin

EXPERIMENTAL
Drug: Gastrografin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GastrografinDRUG
Gastrografin
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years.
  • Current inpatient following elective laparoscopic or open surgery.
  • Classified as having prolonged postoperative ileus.
  • Able to understand risks/benefits of the study.
  • Able to give informed consent.

You may not qualify if:

  • Pregnancy.
  • ASA of 4 or greater.
  • Previous allergic reaction to gastrografin or iodinated contrast agents.
  • Manifest hyperthyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auckland City Hospital

Auckland, AKL, 1010, New Zealand

Location

MeSH Terms

Interventions

Diatrizoate Meglumine

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsDiatrizoateTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 25, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 4, 2014

Record last verified: 2014-07

Locations

NZ(1)