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

NCT01440712 | Completed Phase 4 DMC

• 2 other identifiers: Ileus_gastro2010-024096-87
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Ileus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hospital stay after diagnosis of ileus

  While the patient is admitted to the hospital. An average of 11 days since the intervention.

• Percentage of patients requiring total parenteral nutrition.

  While the patient is admitted to the hospital. An average of 11 days since the intervention

• Presence of postoperative pain and analgesic required

  While the patient is admitted to the hospital. An average of 11 days since the intervention

• Percentage of mortality during hospitalization.

  While the patient is admitted to the hospital. An average of 11 days since the intervention

Study Arms (2)

Gastrografin

EXPERIMENTAL

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

physiological serum

PLACEBO COMPARATOR

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

Interventions

Gastrografin DRUG

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

Gastrografin

physiological serum DRUG

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

physiological serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (3)

Hospital Universitari de la Vall d´Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitari de Girona

Girona, Girona, 17007, Spain

Location

Related Publications (8)

• 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.

  PMID: 15884127 BACKGROUND

• 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.

  PMID: 12734858 BACKGROUND

• 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.

  PMID: 17380561 BACKGROUND

• 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.

  PMID: 17435541 BACKGROUND

• 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.

  PMID: 2256758 BACKGROUND

• 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.

  PMID: 7710343 BACKGROUND

• 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.

  PMID: 11091234 BACKGROUND

• 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.

  PMID: 26446450 DERIVED

MeSH Terms

Interventions

Diatrizoate Meglumine

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Sebastiano Biondo, Dr.

  Bellvitge University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 26, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

ES (3)