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

Catalan Institute of Health

Status and phase: Completed; Phase 4

Conditions: Postoperative Ileus

Treatments: Drug: physiological serum; Drug: Gastrografin

Study type: Interventional

Funder types: Other

Identifiers

NCT01440712

Ileus_gastro

2010-024096-87 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Gastrografin

Experimental group

Description:

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.

Treatment:

Drug: Gastrografin

physiological serum

Placebo Comparator group

Description:

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.

Treatment:

Drug: physiological serum