Status:
COMPLETED
Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
Lead Sponsor:
Hospital Universitari de Bellvitge
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01440712
Start Date
December 1 2011
End Date
December 1 2013
Last Update
July 15 2014
Active Locations (3)
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1
Hospital Universitari de la Vall d´Hebron
Barcelona, Barcelona, Spain, 08035
2
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitari de Girona
Girona, Girona, Spain, 17007