Gastrografin for Treating Small Bowel Obstruction in Children

NCT03573921 | Terminated Phase 2

• 1 other identifier: LHSC032018
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-centre clustered open label clinical trial testing the effectiveness of adding Gastrografin to standard non-surgical management of small bowel obstruction. Gastrografin is a radiopaque contract agent that exhibits a mild laxative effective due to its high osmolarity and ability to pull water into the intestines and bowels as a lubricant. Small bowel obstruction is a mechanical or function obstruction that prevents normal bowel function. The standard treatment for small bowel obstruction is non-surgical and includes decompressing the abdomen, fluid resuscitation, nothing by mouth, and time. In some cases if non-surgical management is not effective in resolving the obstruction, surgical intervention is required. Gastrografin in addition to standard non-surgical management has been shown to reduce the rate of surgery, length of hospital stay, and time to resolution in similar clinical scenarios, such as meconium ileus and meconium plug syndrome. However, it has never been tested in children with small bowel obstruction. This study is a clustered open label study, meaning that each participating centre will select the type of treatment they will offer at their centre. The treatment options are either the Gastrografin arm (a single dose of Gastrografin plus non-surgical management) or the Control arm (a single dose of saline solution plus non-surgical management). After each group receives saline or Gastrografin they will continue with the same non-surgical treatment that patients not participating in the trial would receive. Participating in the study does not preclude the need for urgent or emergent surgical intervention and at any point in the study, if the patient requires surgery for their small bowel obstruction they will undergo surgical intervention. The outcomes of this study are the rate of surgical intervention, length of stay, time to first and full feeds, and rate of complications.

Conditions

Small Bowel Obstruction

Keywords

Paediatrics; Gastrografin

Outcome Measures

Primary Outcomes (1)

• rate of surgical intervention

  number of patients who require surgical intervention to resolve their bowel obstruction after receiving either treatment.

  Through study completion, up to 6 months

Secondary Outcomes (4)

• Length of hospital stay

  Through study completion, up to 6 months

• Time to first feed

  Through study completion, up to 6 months

• Time to full feeds

  Through study completion, up to 6 months

• Rate of complications

  Through study completion, up to 6 months

Study Arms (2)

Gastrografin Arm

EXPERIMENTAL

Patients will receive a single dose of undiluted Gastrografin via the nasogastric tube at 24 hours after admission for small bowel obstruction. The dose of Gastrografin will be proportional to the patient's weight and age and will be based off of the recommendations from the drug manufacturer. Dosages will range from 30 ml for infants to children less than 5 years old and 60 ml for children 5-18 years and will not be diluted.

Drug: Gastrografin

Control Arm

EXPERIMENTAL

Patients will receive a single dose of saline solution via the nasogastric tube at 24 hours after admission for small bowel obstruction. The volume of saline solution will be proportional to the volume of Gastrografin patients of similar weight and age would receive.

Other: Saline solution (control treatment)

Interventions

Gastrografin DRUG

Patients will receive a single dose of Gastrografin via the nasogastric tube at 24 hours after hospital admission. After receiving Gastrografin, patients will receive the same standard non-surgical management that patients outside of the trial receive.

Also known as: diatrizoate meglumine and diatrizoate sodium solution

Gastrografin Arm

Saline solution (control treatment) OTHER

Patients will receive a single dose of saline solution via the nasogastric tube at 24 hours after hospital admission. After receiving saline solution, patients will receive the same standard non-surgical management that patients outside of the trial receive.

Control Arm

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed small bowel obstruction by a surgeon or physician
• Patient has undergo 24 hours of monitoring and non-surgical management (NG tube decompression, IV fluids, and NPO)
• Patients are between 6 month and 18 years of age at time of diagnosis

You may not qualify if:

• Abnormal levels of thyroid stimulating hormone (TSH) or thyroxine (T4)
• Prior thyroid surgery
• Receiving thyroid hormone replacement therapy
• Allergy to medical or non-medial ingredients in Gastrografin
• Weight of less than 10kg at time of diagnosis

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (5)

• 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.

  PMID: 11479852 BACKGROUND

• 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.

  PMID: 12077756 BACKGROUND

• 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.

  PMID: 29501236 BACKGROUND

• 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.

  PMID: 19575766 BACKGROUND

• 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.

  PMID: 36102499 DERIVED

MeSH Terms

Interventions

Diatrizoate Meglumine; Saline Solution

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Diatrizoate; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clustered study, where each centre will select which of the two study arms (Gastrografin or Saline solution) they will offer at their centre.

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 29, 2018
• Study Start: September 1, 2019
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CA (1)