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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024096-87 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrografin | Drug | Administration of 100 ml of gastrografin by the nasogastric tube, only once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay after diagnosis of ileus | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged. | While the patient is admitted to the hospital. An average of 11 days since the intervention. |
| Percentage of patients requiring total parenteral nutrition. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Biondo, Dr. | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de la Vall d´Hebron | Barcelona | Barcelona | 08035 | Spain | ||
| Hospital Universitari Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15884127 | Background | 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. | |
| 12734858 | 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. |
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| ID | Term |
|---|---|
| D003974 | Diatrizoate Meglumine |
| ID | Term |
|---|---|
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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| physiological serum | Drug | Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once. |
|
Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged |
| While the patient is admitted to the hospital. An average of 11 days since the intervention |
| Presence of postoperative pain and analgesic required | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged | While the patient is admitted to the hospital. An average of 11 days since the intervention |
| Percentage of mortality during hospitalization. | Postoperative complications were assessed in the intervening period between the immediate postoperative phase and when the patient is discharged | While the patient is admitted to the hospital. An average of 11 days since the intervention |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Hospital Universitari de Girona | Girona | Girona | 17007 | Spain |
| 17380561 | 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. |
| 17435541 | 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. |
| 2256758 | 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. |
| 7710343 | 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. |
| 11091234 | 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. |
| 26446450 | Derived | 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. |
| Organic Chemicals |
| D003973 | Diatrizoate |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |