Postoperative paralytic Ileus MedDRA version: 17.1 Level: LLT Classification code 10033841 Term: Paralytic ileus System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Gastrografin
Pharmaceutical Form: Oral solution
INN or Proposed INN: MEGLUMINE AMIDOTRIZOATE
CAS Number: 131-49-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
Fundacio Parc Taulí
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study the effect of Gastrografin on the duration of postoperative ileus in patients that have been submitted to abdominal surgery, versus conventional conservative treatment.;Secondary Objective: 1) Compare hospital stay (days) between patients who have received Gastrografin versus the ones that have received the conservative treatment. 2) Compare the incidence of complications due to postoperative ileus (dehydration, accute renal insufficiency, complications derived from the nasogastric tube placement or parenteral nutrition) between the two groups.;Primary end point(s): Time to ressolution of postoperative ileus to, defined by prolonged tolerance of P3 diet during 48 hours.;Timepoint(s) of evaluation of this end point: The study endpoints will be assessed continuously up to the ressolution of the ileus. The follow-up of the patient is going to consist in, at least, one visit per day. The tolerance of P3 diet must be prolonged at least 48 hours. The moment when the patient accomplish this condition is going to be recordered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to hospital discharge. - Complications related with postoperative ileus - Time to first deposition after the appearance of postoperative ileus.;Timepoint(s) of evaluation of this end point: The study endpoints will be assessed continuously up to the ressolution of the ileus and hospital discharge. The follow-up of the patient is going to consist in, at least, one visit per day. The tolerance of P3 diet must be prolonged at least 48 hours. | — |
Countries
Spain
Contacts
Public ContactServei de cirurgia general i digest
Hospital Universitari Parc Taulí
Outcome results
None listed