Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Mucosal Resection (EMR) | Procedure | EMR is a common procedure in gastroenterology. The technique involves placing a band around a piece of mucosa in the GI tract. The band and the tissue are then removed using a cautery snare. The technique can be used to obtain tissue for diagnostic purposes or to remove lesions for therapeutic purposes. |
| Measure | Description | Time Frame |
|---|---|---|
| The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy. | April 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain. | April 2009 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Field F Willingham, MD, MPH | MGH | Study Director |
| Garrett C Zella, MD | MGH | Study Director |
| Mari Mino-Kenudson, MD | MGH | Study Director |
| Braden Kuo, MD | MGH | Principal Investigator |
| William R Brugge, MD, FASGE | MGH | Study Director |
| Leonel Rodriguez, MD | MGH | Principal Investigator |
| Clarissa Foy, NP | MGH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hosptial | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D006627 | Hirschsprung Disease |
| D003248 | Constipation |
| D004194 | Disease |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D007410 |
| Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |