Indocyanine green for Anorectal Malformations

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Anorectal Malformations+1 MoreIndocyanine green - Drug
Eligibility
1 - 7
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a medication can help reduce the risk of complications in children with Hirschsprung's disease and anorectal malformations.

Eligible Conditions
  • Anorectal Malformations
  • Hirschsprung Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: 12 months

12 months
The number of eligible paediatric patients treated for HD or ARM at the local institute that would qualify for participation in this trial.
The number of eligible paediatric patients treated for HD or ARM that enroll in this study and attend al required study visits.
The number of eligible paediatric patients treated for HD or ARM that enroll in this study during the recruitment period of this study.
The number of eligible paediatric patients treated for HD or ARM that enrolled in this study but are lost to attrition/drop-out during the study
2 weeks
If the use of ICG alters the length of stay in hospital between ICG and control group
5 hours
If the use of ICG alters the intraoperative management of the patient, resulting in the surgeon resecting a longer segment of bowel.
If the use of ICG alters the length of operative time between ICG and control group
Week 2
Adverse reaction to ICG resulting in adverse events/complications
Adverse reaction to ICG resulting in anaphylaxis
Adverse reaction to ICG resulting in drug interactions
Adverse reaction to ICG resulting in urticarial reactions
Month 6
Rate of an additional related procedure under general anaesthesia (i.e. return to the operating room or interventional radiology)
Rate of anal stricture (moderate or severe) requiring anal dilatations
Rate of hospital readmission in the first 30 days postoperatively
Rates of anal stricture (mild) not requiring anal dilatations
Rates of anastomotic dehiscence

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Indocyanine Green
97%Wound pain
40%Nausea
13%Ileus
10%Vomiting
7%Bloating
7%Urinary tract infection
3%Distended abdomen
3%Atrial fibrillation
3%Urinary retention
3%Constipations
3%Hiccough
3%Low blood pressure
3%Febrile reaction
3%Epigastric pain
3%Rigors
3%Groin pain
3%Atelectasis
3%Palpitations
3%Tremor
3%Low haemoglobin
3%Confusion
3%Paroxysmal atrial fibrillation
3%Postoperative ileus
3%Dizziness
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT01662752) in the Indocyanine Green ARM group. Side effects include: Wound pain with 97%, Nausea with 40%, Ileus with 13%, Vomiting with 10%, Bloating with 7%.

Trial Design

2 Treatment Groups

Control Arm (Standard Care)
1 of 2
Treatment Arm (Indocyanine Green [ICG])
1 of 2

Active Control

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Indocyanine green · No Placebo Group · Phase 3

Treatment Arm (Indocyanine Green [ICG])
Drug
Experimental Group · 1 Intervention: Indocyanine green · Intervention Types: Drug
Control Arm (Standard Care)NoIntervention Group · 1 Intervention: Control Arm (Standard Care) · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine green
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
613 Previous Clinical Trials
402,109 Total Patients Enrolled
Andreana Butter, MDPrincipal InvestigatorPediatric Surgeon, Children's Hospital, LHSC

Eligibility Criteria

Age 1 - 7 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Medical history Clinical evaluation and physical examination The patient's medical history is reviewed
The aim of this study was to investigate the accuracy of pathologic diagnosis after rectal biopsies in patients with hematochezia (HD)
who were undergoing elective surgery for inguinal hernia were eligible for the study Patients greater than one-month of age who were undergoing elective surgery for inguinal hernia were eligible for the study.
SDMs who are not capable of understanding English If an SDM is not capable of understanding English, a translator will be needed to communicate with the patient.
The patient needs surgery to treat their condition.
References