Skip to main content
OpenTrials
Completed

NCT Number: NCT01440712

Study of the Effect of Water Soluble Oral Contrast (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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari de la Vall d´Hebron, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Neoplasia.
  • Inflammatory disease.
  • 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:
  • Anastomotic leakages.
  • Mesenteric vascular disease.
  • Incarcerated hernias.
  • Intra-abdominal abscesses or collections.
  • 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.

Treatment and study plan

Gastrografin

Drug

Administration of 100 ml of gastrografin by the nasogastric tube, only once.

physiological serum

Drug

Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2011
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.