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

This study is currently recruiting participants.
Verified June 2012 by Hospital Universitari de Bellvitge
Sponsor:
Collaborator:
Instituto de Salud Carlos III, Ministry of Science and Innovation. Spain
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01440712
First received: September 21, 2011
Last updated: June 10, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Ileus
 Drug: Gastrografin
Drug: physiological serum
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay after diagnosis of ileus [ Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention. ] [ Designated as safety issue: Yes ]
    Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged.

  • 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 ] [ Designated as safety issue: Yes ]
    Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged

  • 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 ] [ Designated as safety issue: Yes ]
    Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged

  • Percentage of mortality during hospitalization. [ Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention ] [ Designated as safety issue: Yes ]
    Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged


Estimated Enrollment: 58
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440712

Contacts
Contact: Sebastiano Biondo, Dr. 0034 93 260 75 23 sbiondo@bellvitgehospital.cat

Locations
Spain
Bellvitge University Hospital Recruiting
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Sebastiano Biondo, Dr.     0034 93 260 75 23     sbiondo@bellvitgehospital.cat    
Principal Investigator: Sebastiano Biondo, Dr.            
Bellvitge University Hospital Not yet recruiting
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Sebastiano Biondo, Dr.     0034 93 260 75 23     sbiondo@bellvitgehospital.cat    
Principal Investigator: Sebastiano Biondo, Dr.            
Sponsors and Collaborators
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III, Ministry of Science and Innovation. Spain
Investigators
Principal Investigator: Sebastiano Biondo, Dr. Bellvitge University Hospital
  More Information

Publications:

Responsible Party: Sebastiano Biondo, Principal investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01440712     History of Changes
Other Study ID Numbers: Ileus_gastro, 2010-024096-87
Study First Received: September 21, 2011
Last Updated: June 10, 2012
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Gastrografin
Postoperative ileus
Colo-rectal surgery
Effects on morbidity and mortality of postoperative ileus

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013