Study of the Effect of Water Soluble Oral Contrast (Gastrografin) on Postoperative Ileus After Colorectal Surgery
NCT ID: NCT01440712
Last Updated: 2014-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2011-12-31
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Gastrografin in Postoperative Ileus
NCT01648972
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation
NCT02784093
Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
NCT02040285
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
NCT00389116
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing Bowel Resection
NCT02836470
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gastrografin
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.
Gastrografin
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
physiological serum
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.
physiological serum
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gastrografin
Administration of 100 ml of gastrografin by the nasogastric tube, only once.
physiological serum
Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitari de Bellvitge
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sebastiano Biondo
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sebastiano Biondo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Bellvitge University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitari de la Vall d´Hebron
Barcelona, Barcelona, Spain
Hospital Universitari Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari de Girona
Girona, Girona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-024096-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Ileus_gastro
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.