Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery

July 12, 2014 updated by: Sebastiano Biondo, Hospital Universitari de Bellvitge

Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery

The purpose of this trial is to determine whether the water-soluble contrast (gastrografin) is more effective in the treatment of postoperative ileus than the conventional one.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari de La Vall D´Hebron
      • Girona, Spain, 17007
        • Hospital Universitari de Girona
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with postoperative ileus after colorectal surgery, defined as the presence from the third postoperative day, abdominal distension, nausea, vomiting with or without abdominal pain or discomfort by dilation of bowel loops, confirmed radiology of the abdomen, and which are: Age > 18 years Patients undergoing laparotomy or laparoscopy for the following variants of colorectal disease with or without stoma:

    1. Neoplasia.
    2. Inflammatory disease.
    3. Diverticular disease. Patients who have been treated with standard PCA as postoperative analgesia. Signed informed consent. Undergoing elective or scheduled

Exclusion Criteria:

  • Patient's refusal to sign informed consent
  • Pregnancy or lactation

  • Hypersensitivity to iodinated contrast agents (it´s the only contraindication to oral Gastrografin) Presence of other problems that justify the etiology of postoperative ileus:

    1. Anastomotic leakages.
    2. Mesenteric vascular disease.
    3. Incarcerated hernias.
    4. Intra-abdominal abscesses or collections.
    5. Metabolic or electrolyte disturbances. If during the course of the study one of the reasons previously cited as the etiology of postoperative ileus is present, the patient shall also be excluded. Also excluded patients undergoing emergency surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastrografin
Patients located in this group will be treated with the administration of 100 ml of gastrografin by the nasogastric tube, only once, after the diagnosis of postoperative ileus.
Drug: Gastrografin
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
Placebo Comparator: physiological serum
Patients included in this group will be treated with 100 ml of physiological serum 0,9% by the nasogastric tube, only once, after the diagnosis of postoperative ileus.
Drug: physiological serum
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
While the patient is admitted to the hospital. An average of 11 days since the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay after diagnosis of ileus
Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged.
While the patient is admitted to the hospital. An average of 11 days since the intervention.
Percentage of patients requiring total parenteral nutrition.
Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
While the patient is admitted to the hospital. An average of 11 days since the intervention
Presence of postoperative pain and analgesic required
Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
While the patient is admitted to the hospital. An average of 11 days since the intervention
Percentage of mortality during hospitalization.
Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
While the patient is admitted to the hospital. An average of 11 days since the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Investigators

  • Principal Investigator: Sebastiano Biondo, Dr., Bellvitge University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 12, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ileus_gastro
  • 2010-024096-87 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Ileus

Clinical Trials on Gastrografin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe