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

Sponsor

Hospital Universitari de Bellvitge (Other)

Overall Status

Completed

CT.gov ID

NCT01440712

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

19.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Drug: Gastrografin Drug: physiological serum	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Gastrografin Administration of 100 ml of gastrografin by the nasogastric tube, only once.
Placebo Comparator: 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.	Drug: physiological serum Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Gastrografin

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

Placebo Comparator: 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.

Drug: physiological serum

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitari Bellvitge	L´Hospitalet de Llobregat	Barcelona	Spain	08907
2	Hospital Universitari de la Vall d´Hebron	Barcelona		Spain	08035
3	Hospital Universitari de Girona	Girona		Spain	17007