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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440712
• Other study ID #: Ileus_gastro
• Secondary ID: 2010-024096-87
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2011
• Last updated: July 12, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of HealthSpain: Ministry of Health and ConsumptionSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Drug:
• Gastrografin
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
• physiological serum
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.

Locations

Country	Name	City	State
Spain	Hospital Universitari de la Vall d´Hebron	Barcelona
Spain	Hospital Universitari de Girona	Girona
Spain	Hospital Universitari Bellvitge	L´Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Abbas SM, Bissett IP, Parry BR. Meta-analysis of oral water-soluble contrast agent in the management of adhesive small bowel obstruction. Br J Surg. 2007 Apr;94(4):404-11. Review. — View Citation

Biondo S, Parés D, Mora L, Martí Ragué J, Kreisler E, Jaurrieta E. Randomized clinical study of Gastrografin administration in patients with adhesive small bowel obstruction. Br J Surg. 2003 May;90(5):542-6. — View Citation

Böhm B, Milsom JW, Fazio VW. Postoperative intestinal motility following conventional and laparoscopic intestinal surgery. Arch Surg. 1995 Apr;130(4):415-9. — View Citation

Chen JH, Hsieh CB, Chao PC, Liu HD, Chen CJ, Liu YC, Yu JC. Effect of water-soluble contrast in colorectal surgery: a prospective randomized trial. World J Gastroenterol. 2005 May 14;11(18):2802-5. — View Citation

Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. — View Citation

Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. Review. — View Citation

Waldhausen JH, Schirmer BD. The effect of ambulation on recovery from postoperative ileus. Ann Surg. 1990 Dec;212(6):671-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes