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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01440712
Enrollment
58
Registered
2011-09-26
Start date
2011-12-31
Completion date
2013-12-31
Last updated
2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

Gastrografin, Postoperative ileus, Colo-rectal surgery, Effects on morbidity and mortality of postoperative ileus

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.

Interventions

Administration of 100 ml of gastrografin by the nasogastric tube, only once.

Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Hospital stay after diagnosis of ileusWhile 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 interventionPostoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged
Presence of postoperative pain and analgesic requiredWhile the patient is admitted to the hospital. An average of 11 days since the interventionPostoperative 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 interventionPostoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026