Clinical trial NCT01440712: Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
Official title: Prospective Randomized Double Blind Study of the Effect of Gastrografin on Postoperative Ileus After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Ileus
Keywords: Gastrografin
Postoperative ileus
Colo-rectal surgery
Effects on morbidity and mortality of postoperative ileus
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to resolution of postoperative ileus after surgery defined as time to tolerance of oral intake of solid or semisolid food
timeFrame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
Secondary outcomes:
measure: Hospital stay after diagnosis of ileus
timeFrame: While the patient is admitted to the hospital. An average of 11 days since the intervention.
measure: Percentage of patients requiring total parenteral nutrition.
timeFrame: While the patient is admitted to the hospital. An average of 11 days since the intervention
measure: Presence of postoperative pain and analgesic required
timeFrame: While the patient is admitted to the hospital. An average of 11 days since the intervention
measure: Percentage of mortality during hospitalization.
timeFrame: While the patient is admitted to the hospital. An average of 11 days since the intervention
Other outcomes:
Locations:
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d´Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona
Study officials:
affiliation: Bellvitge University Hospital
name: Sebastiano Biondo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.3748/wjg.v11.i18.2802.
citation: Biondo S, Pares D, Mora L, Marti Rague 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. doi: 10.1002/bjs.4150.
citation: 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. doi: 10.1002/bjs.5775.
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. doi: 10.1097/01.sla.0000232538.72458.93.
citation: Waldhausen JH, Schirmer BD. The effect of ambulation on recovery from postoperative ileus. Ann Surg. 1990 Dec;212(6):671-7. doi: 10.1097/00000658-199012000-00004.
citation: Bohm B, Milsom JW, Fazio VW. Postoperative intestinal motility following conventional and laparoscopic intestinal surgery. Arch Surg. 1995 Apr;130(4):415-9. doi: 10.1001/archsurg.1995.01430040077017.
citation: Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
citation: Biondo S, Miquel J, Espin-Basany E, Sanchez JL, Golda T, Ferrer-Artola AM, Codina-Cazador A, Frago R, Kreisler E. A Double-Blinded Randomized Clinical Study on the Therapeutic Effect of Gastrografin in Prolonged Postoperative Ileus After Elective Colorectal Surgery. World J Surg. 2016 Jan;40(1):206-14. doi: 10.1007/s00268-015-3260-9.