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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: Gastrografin
* Drug: physiological serum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastrografin<br>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<br>* Administration of 100 ml of gastrografin by the nasogastric tube, only once.<br>|
| Placebo Comparator: physiological serum<br>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<br>* Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay after diagnosis of ileus | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged. | While the patient is admitted to the hospital. An average of 11 days since the intervention. | 
| Percentage of patients requiring total parenteral nutrition. | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged | While the patient is admitted to the hospital. An average of 11 days since the intervention | 
| Presence of postoperative pain and analgesic required | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged | While the patient is admitted to the hospital. An average of 11 days since the intervention | 
| Percentage of mortality during hospitalization. | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged | While the patient is admitted to the hospital. An average of 11 days since the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus