Study Summary
This trial is testing whether adding Gastrografin to standard non-surgical management of small bowel obstruction is effective.
- Small Bowel Obstruction
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Through study completion, up to 6 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Control Arm
1 of 2
Gastrografin Arm
1 of 2
Experimental Treatment
146 Total Participants · 2 Treatment Groups
Primary Treatment: Gastrografin · No Placebo Group · Phase 2 & 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 18 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Ahmet, Alexandra, Margaret L Lawson, Paul Babyn, and Andrea C Tricco. 2009. “Hypothyroidism in Neonates Post-iodinated Contrast Media: A Systematic Review”. Acta Paediatrica. Wiley. doi:10.1111/j.1651-2227.2009.01412.x.
- St-Louis, Etienne, Marcus Oosenbrug, Tara Landry, and Robert Baird. 2018. “Enrollment and Reporting Practices in Pediatric General Surgical Randomized Clinical Trials: A Systematic Review and Observational Analysis”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2018.02.009.
- Moss, R.Lawrence, Marion C.W. Henry, Reed A. Dimmitt, Shawn Rangel, Nora Geraghty, and Erik D. Skarsgard. 2001. “The Role of Prospective Randomized Clinical Trials in Pediatric Surgery: State of the Art?”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1053/jpsu.2001.25749.
- Rangel, Shawn J., Balasubramanian Narasimhan, Nora Geraghty, and R.Lawrence Moss. 2002. “Development of an Internet-based Protocol to Facilitate Randomized Clinical Trials in Pediatric Surgery”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1053/jpsu.2002.33826.
- Emil S, Guadagno E, Baird R, Puligandla P, Romao R, Van HouWelingen L, Yanchar NL; Canadian Consortium for Research in Pediatric Surgery (CanCORPS). The Canadian Consortium for Research in Pediatric Surgery: Roadmap for Creation and Implementation of a National Subspecialty Research Consortium. J Am Coll Surg. 2022 Dec 1;235(6):952-961. doi: 10.1097/XCS.0000000000000396. Epub 2022 Nov 15.
- Ahmet A, Lawson ML, Babyn P, Tricco AC. Hypothyroidism in neonates post-iodinated contrast media: a systematic review. Acta Paediatr. 2009 Oct;98(10):1568-74. doi: 10.1111/j.1651-2227.2009.01412.x. Epub 2009 Jul 3.
- St-Louis E, Oosenbrug M, Landry T, Baird R. Enrollment and reporting practices in pediatric general surgical randomized clinical trials: A systematic review and observational analysis. J Pediatr Surg. 2018 May;53(5):879-884. doi: 10.1016/j.jpedsurg.2018.02.009. Epub 2018 Feb 8.
- Moss RL, Henry MC, Dimmitt RA, Rangel S, Geraghty N, Skarsgard ED. The role of prospective randomized clinical trials in pediatric surgery: state of the art? J Pediatr Surg. 2001 Aug;36(8):1182-6. doi: 10.1053/jpsu.2001.25749.
- Rangel SJ, Narasimhan B, Geraghty N, Moss RL. Development of an internet-based protocol to facilitate randomized clinical trials in pediatric surgery. J Pediatr Surg. 2002 Jul;37(7):990-4; discussion 990-4. doi: 10.1053/jpsu.2002.33826.
- 2019. "Gastrografin for Treating Small Bowel Obstruction in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03573921.
Frequently Asked Questions
Why is Gastrografin given to patients?
"Gastrografin is an effective agent for retrograde cystourethrography, arteriography, and computerized tomography." - Anonymous Online Contributor
Are there any open positions in this trial for willing participants?
"That is accurate. According to the information available on clinicaltrials.gov, this trial was posted on September 1st, 2019 and is currently recruiting patients. The study plans to admit a total of 146 participants from one site." - Anonymous Online Contributor
Does this research include patients who are octogenarians or above?
"Children aged 6 months to 18 years old may qualify for this particular trial, though there are other studies more suited for different age groups. For example, there are 3 trials specifically designed for those under 18 and 13 trials investigating treatments for seniors above the age of 65." - Anonymous Online Contributor
What is the research history of Gastrografin?
"Currently, there is 1 trial studying Gastrografin that is in Phase 3. Out of the total trials for Gastrografin, most are located in London, Ontario with one other location running a study." - Anonymous Online Contributor
How many people are partaking in this clinical trial at most?
"That is accurate. The listing on clinicaltrials.gov says that the research team is still looking for participants. This study was first made public on September 1st, 2019 and had new information added as recently as April 5th, 2022. So far, 146 people have signed up to take part in this experiment at a single location." - Anonymous Online Contributor
Could I possibly join this clinical trial?
"Eligible patients for this trial must have intestinal obstruction and be between 6 months old to 18 years old. The study is looking to enroll 146 participants in total." - Anonymous Online Contributor