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Establishment and optimization of intraoperative pathological criteria for surgical margin assessment in Hirschsprung disease based on characteristic changes in ganglion cells

Establishment and optimization of intraoperative pathological criteria for surgical margin assessment in Hirschsprung disease based on characteristic changes in ganglion cells

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103966
Enrollment
Unknown
Registered
2025-06-09
Start date
2023-07-25
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Hirschsprung disease

Interventions

Gold Standard:Pathologic gold standard of transition zone:(1) complete absence of ganglion cells of a segment equal to >1/8 of the circumference in the submucosal and/or myenteric plexuses (2) a segm
Index test:Based on the intraoperative rapid pathological grading system for congenital Hirschsprung disease used at our institution, the slides were classified into six categories according to the as

Sponsors

Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with histopathologically confirmed Hirchsprung Disease, including short-segment HSCR, long-segment HSCR and total colon aganglionosis. 2. Complete clinical data and pathological information; 3. Patients who signed written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. The pathologic diagnosis is intestinal neuronl dysplasia; 2. The pathologic diagnosis is chronic intestinal pesudo-obstruction. 3. Combined with chromosomal abnormalities and other congenital disorders.

Design outcomes

Primary

MeasureTime frame
the area under the receiver operating characteristic (AUC);Accuracy;Sensitivity;Specificity;Positive predictive values;Negative predictive values;Kappa;

Countries

China

Contacts

Public ContactZhang Minzhong

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

zhangminzhong@outlook.com+86 185 1605 7500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026