NCT05307419

Brief Summary

The objective of this prospective study is to compare the diagnostic accuracy of rectal suction biopsy (RSB) compared to full thickness rectal biopsy (FTB) in the diagnosis of Hirschsprungs Disease (HD) in children. The secondary objective to compare cost-effectiveness of the two procedures

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

February 2, 2022

Last Update Submit

May 16, 2022

Conditions

Hirschsprung Disease

Keywords

Hirschsprungs diseaseRectal biopsyRectal suction biopsyFull thickness biopsyRandomisedBlindedMb. Hirschsprung

Outcome Measures

Primary Outcomes (1)

  • Number of inconclusive biopsies between FTB and RSB.

    Prospective comparison of RSB and FTB when performed on the same patient. Evaluation of diagnostic accuracy.

    30 days

Secondary Outcomes (1)

  • Surgical and pathology cost.

    30 days

Study Arms (2)

Rectal suction biopsy first

ACTIVE COMPARATOR

Children randomised for pahtological evaluation of rectal suction biopsy tissue first.

Procedure: Rectal suction biopsy.Procedure: Full-thickness rectal biopsy.

Full thickness biopsy first

ACTIVE COMPARATOR

Children randomised for pathological evaluation of full thickness biopsy tissue first.

Procedure: Rectal suction biopsy.Procedure: Full-thickness rectal biopsy.

Interventions

Rectal suction biopsy.PROCEDURE

Suction biopsy performed

Full thickness biopsy firstRectal suction biopsy first
Full-thickness rectal biopsy.PROCEDURE

Full-thickness biopsy performed

Full thickness biopsy firstRectal suction biopsy first

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients that are referred for rectal biopsy for suspected HD, age 0-15 years.
  • Written informed consent of the parents or guardian.

You may not qualify if:

  • Lack of consent from parents or guardians.
  • Previous surgery on the ano-rectum e.g. crohns disease and/or fistulas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

RECRUITING

Related Publications (10)

  • Muise ED, Hardee S, Morotti RA, Cowles RA. A comparison of suction and full-thickness rectal biopsy in children. J Surg Res. 2016 Mar;201(1):149-55. doi: 10.1016/j.jss.2015.10.031. Epub 2015 Oct 28.

    PMID: 26850196BACKGROUND

  • Bjorn N, Rasmussen L, Qvist N, Detlefsen S, Ellebaek MB. Full-thickness rectal biopsy in children suspicious for Hirschsprung's disease is safe and yields a low number of insufficient biopsies. J Pediatr Surg. 2018 Oct;53(10):1942-1944. doi: 10.1016/j.jpedsurg.2018.01.005. Epub 2018 Jan 31.

    PMID: 29426767BACKGROUND

  • Alizai NK, Batcup G, Dixon MF, Stringer MD. Rectal biopsy for Hirschsprung's disease: what is the optimum method? Pediatr Surg Int. 1998 Mar;13(2-3):121-4. doi: 10.1007/s003830050264.

    PMID: 9563023BACKGROUND

  • Stewart CL, Kulungowski AM, Tong S, Langer JC, Soden J, Somme S. Rectal biopsies for Hirschsprung disease: Patient characteristics by diagnosis and attending specialty. J Pediatr Surg. 2016 Apr;51(4):573-6. doi: 10.1016/j.jpedsurg.2015.10.047. Epub 2015 Oct 19.

    PMID: 26592956BACKGROUND

  • Friedmacher F, Puri P. Rectal suction biopsy for the diagnosis of Hirschsprung's disease: a systematic review of diagnostic accuracy and complications. Pediatr Surg Int. 2015 Sep;31(9):821-30. doi: 10.1007/s00383-015-3742-8. Epub 2015 Jul 9.

    PMID: 26156878BACKGROUND

  • Imaizumi T, Murakami H, Nakamura H, Seo S, Koga H, Miyano G, Okawada M, Doi T, Lane GJ, Okazaki T, Arakawa A, Yao T, Yamataka A. Rectal mucosal/submucosal biopsy under general anesthesia ensures optimum diagnosis of bowel motility disorders. Pediatr Surg Int. 2016 Dec;32(12):1173-1176. doi: 10.1007/s00383-016-3976-0. Epub 2016 Sep 23.

    PMID: 27663688BACKGROUND

  • Pini-Prato A, Martucciello G, Jasonni V. Rectal suction biopsy in the diagnosis of intestinal dysganglionoses: 5-year experience with Solo-RBT in 389 patients. J Pediatr Surg. 2006 Jun;41(6):1043-8. doi: 10.1016/j.jpedsurg.2006.01.070.

    PMID: 16769331BACKGROUND

  • Ali AE, Morecroft JA, Bowen JC, Bruce J, Morabito A. Wall or machine suction rectal biopsy for Hirschsprung's disease: a simple modified technique can improve the adequacy of biopsy. Pediatr Surg Int. 2006 Aug;22(8):681-2. doi: 10.1007/s00383-006-1714-8. Epub 2006 Jul 4.

    PMID: 16821022BACKGROUND

  • Hall NJ, Kufeji D, Keshtgar A. Out with the old and in with the new: a comparison of rectal suction biopsies with traditional and modern biopsy forceps. J Pediatr Surg. 2009 Feb;44(2):395-8. doi: 10.1016/j.jpedsurg.2008.10.093.

    PMID: 19231542BACKGROUND

  • De Lorijn F, Reitsma JB, Voskuijl WP, Aronson DC, Ten Kate FJ, Smets AM, Taminiau JA, Benninga MA. Diagnosis of Hirschsprung's disease: a prospective, comparative accuracy study of common tests. J Pediatr. 2005 Jun;146(6):787-92. doi: 10.1016/j.jpeds.2005.01.044.

    PMID: 15973319BACKGROUND

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesMegacolonColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mark mr Ellebaek, Dr

    University of Southern Denmark

    STUDY DIRECTOR

  • Rasmus mr Nielsen, Dr

    Odense University Hospital

    STUDY CHAIR

  • Gunvor ms Madsen, Dr

    Odense University Hospital

    STUDY CHAIR

  • Niels mr Bjorn, Dr

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Lene ms Christensen, Dr

    Odense University Hospital

    STUDY CHAIR

Central Study Contacts

Niels mr Bjorn, Dr

CONTACT

23241781niels.bjorn@rsyd.dk

Tina ms Dal Hansen

CONTACT

51326654tina.dal.hansen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The pathologist is masked by 30 day delay and should be conducted by another pathologist than the first.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective randomized blinded case-control study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

April 1, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)