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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sebastiano Biondo, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01440712
First received: September 21, 2011
Last updated: July 12, 2014
Last verified: July 2014

September 21, 2011
July 12, 2014
December 2011
November 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01440712 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Postoperative Ileus
  • Drug: Gastrografin
    Administration of 100 ml of gastrografin by the nasogastric tube, only once.
  • Drug: physiological serum
    Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
  • 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.
    Intervention: Drug: Gastrografin
  • 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.
    Intervention: Drug: physiological serum

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
December 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01440712
Ileus_gastro, 2010-024096-87
Yes
Sebastiano Biondo, Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
Not Provided
Principal Investigator: Sebastiano Biondo, Dr. Bellvitge University Hospital
Hospital Universitari de Bellvitge
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP