Clinical trial about the therapeutic use of diatrizoic acid (Gastrografin®) in postoperative ileus.

Phase 1

• Conditions: Postoperative paralytic Ileus; MedDRA version: 17.1Level: LLTClassification code 10033841Term: Paralytic ileusSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-000473-39-ES
• Lead Sponsor: Fundacio Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-19
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

- Patients older than 18 years old.
- Postoperative ileus.
- Patients that have been submitted to abdominal surgery (including digestive, vascular, gynecologic or urologic procedures). Patients operated for colorectal surgery with protective ostomy.
- Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

- Patients undergoing abdominal surgery that includes intestinal anastomosis without protective ostomy.
- Pregnancy or lactancy.
- Mechanical bowel obstruction.
- Intestinal isquemia
- Allergy to Gastrografin® (or other radiological contrast) or other situation detailed in the Gastrografin's datasheet that contraindicate its use.
- Postoperative complications that could cause paralytic ileus by themselves. (intraabdominal abscess, intraabdominal haematoma,...).
- Patients in whose participation in the clinical trial could cause any damage to their health (based on medical criteria)
- Severe renal failure
- Severe cardiac failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified