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Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial (EDGE Trial)

NCT01515501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-16

No results posted yet for this study

Summary

Patients undergoing routine rectal suction biopsy will undergo as part of the study an additional Endoscopic mucosal resection. The biopsy results will also be correlated with patient's clinical data including clinical history, Bristol stool scale, anorectal manometry results, and SITZ marker studies. Cost and recovery time will be compared.

Conditions

Interventions

PROCEDURE

Endoscopic mucosal resection (EMR)

EMR uses an endoscope to take a tissue sample from the rectum. It is the same type of instrument used in a routine colonoscopy. It is hoped that this procedure will help diagnose Hirschsprung's Disease more often than by recal suction biopsy alone, which can often be unclear and result in more invasive surgery for diagnosis.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Braden Kuo, M.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-02-29
Completion
2018-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515501 on ClinicalTrials.gov