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

Condition(s) targeted: Postoperative Ileus

Intervention: Gastrografin (Drug); physiological serum (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Universitari de Bellvitge

Official(s) and/or principal investigator(s):
Sebastiano Biondo, Dr., Principal Investigator, Affiliation: Bellvitge University Hospital

Overall contact:
Sebastiano Biondo, Dr., Phone: 0034 93 260 75 23, Email: sbiondo@bellvitgehospital.cat

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.

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

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

Primary outcome: Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food

Secondary outcome:

Hospital stay after diagnosis of ileus

Percentage of patients requiring total parenteral nutrition.

Presence of postoperative pain and analgesic required

Percentage of mortality during hospitalization.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sebastiano Biondo, Dr., Phone: 0034 93 260 75 23, Email: sbiondo@bellvitgehospital.cat

Bellvitge University Hospital, L´Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting
Sebastiano Biondo, Dr., Phone: 0034 93 260 75 23, Email: sbiondo@bellvitgehospital.cat
Sebastiano Biondo, Dr., Principal Investigator

Bellvitge University Hospital, L´Hospitalet de Llobregat, Barcelona 08907, Spain; Not yet recruiting
Sebastiano Biondo, Dr., Phone: 0034 93 260 75 23, Email: sbiondo@bellvitgehospital.cat
Sebastiano Biondo, Dr., Principal Investigator

Related publications:

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.

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.

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.

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.

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

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

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

Starting date: December 2011
Last updated: June 10, 2012