Comparison of two different suction rectal biopsy forceps for the diagnosis of Hirschsprung disease in children: A randomised controlled trial

Efficacy of reusable suction rectal biopsy forceps (rbi2®) versus disposable suction rectal biopsy forceps (SBT 200®) for the diagnosis of Hirschsprung disease: A randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001329954

Enrollment

Registered

2020-12-09

Start date

2020-12-01

Completion date

2022-06-15

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomised controlled trial (RCT) will be conducted at Monash Children’s Hospital on infants less than 6 months of age with suspected Hirschsprung disease, requiring a suction rectal biopsy. The study will be an open-label (unblinded) randomised controlled trial: due to the nature of the intervention (i.e. different appearance of the rbi2® and SBT200®) biopsy forceps blinding is not possible. The hypothesis to be tested is that the SBT200® SRB forceps will have lower rates of inadequate specimen sampling, lower re-biopsy rates and lower or comparable complication rates. The proposed sample size for this trial is 40 children in total with 20 in each arm. Since the SBT200® is a brand-new device, no data is available regarding the rate of insufficient biopsy. The sample size has been chosen on feasibility based on the number of patients investigated for Hirschsprung disease each year at Monash Children’s Hospital (20-30) with the aim of completing the trial within 18-24 months. Primary endpoints for the trial will be the effectiveness and the complications with each SRB forceps - Number of biopsies attempted at each episode - Number of inadequate specimens obtained - Number of biopsy episodes performed - Complications: o Bleeding requiring admission/blood transfusion o Rectal perforation o Pelvic abscess/sepsis

Interventions

Infants randomised into the SBT200® group, will undergo suction rectal biopsy with a fully disposable SBT200® SRB forceps. The suction rectal biopsy is a standard procedure performed in children with suspected Hirschsprung disease. The time take for the biopsy is normally 20 minutes. The biopsy will be taken by a paediatric surgeon.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 6 Months

Healthy volunteers

Inclusion criteria

All infants less than 6 months of age requiring a suction rectal biopsy to confirm the diagnosis of Hirschsprung disease will be eligible for the study.

Exclusion criteria

All infants over 6 months of age, those infants who have significant co morbidities such as cardiovascular instability and bleeding diathesis will be excluded from the study.

Outcome results