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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01440712
• Date of registration: 21/09/2011
• Primary sponsor: Hospital Universitari de Bellvitge
• Public title: Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
• Scientific title: Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
• Date of first enrolment: December 2011
• Target sample size: 58
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01440712
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Sebastiano Biondo, Dr.

• Name: Sebastiano Biondo, Dr.
• Affiliation: Bellvitge University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Ileus

Intervention(s)

Drug: Gastrografin

Drug: physiological serum

Primary Outcome(s)

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 Outcome(s)

Hospital stay after diagnosis of ileus [Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention.]

Percentage of mortality during hospitalization. [Time Frame: While the patient is admitted to the hospital. An average of 11 days since the intervention]

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]

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]

Secondary ID(s)

2010-024096-87

Ileus_gastro

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Salud Carlos III, Ministry of Science and Innovation. Spain