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

Phase 4

Completed

• Conditions: Postoperative Ileus
• Interventions: Drug: physiological serum; Drug: Gastrografin

• Registration Number: NCT01440712
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Study Start: 2011-12
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-12
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physiological serum	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.
Gastrografin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Presence of postoperative pain and analgesic required	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
Percentage of mortality during hospitalization.	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
Hospital stay after diagnosis of ileus	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.
Percentage of patients requiring total parenteral nutrition.	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