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GI Neuromuscular Pathology Prospective Registry

GI Neuromuscular Pathology Prospective Registry

Recruiting
6-90 years
All
Phase N/A

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Overview

In this research study, biopsy samples will be collected to provide more insight into the underlying cause of the motility disorders, help direct further investigation into the cause of the underlying condition, provide future prognosis and predict response to gastric electrical stimulation (GES).

Description

Biopsies will be collected from patients that have been diagnosed with gastroparesis (having nausea, retching, bloating and fullness of stomach) and are undergoing surgery for the GES implantation. These patients will serve as our study group population. Biopsy samples of those who do not have gastroparesis but are undergoing surgery on the digestive system will be collected after the patients consent to be on the trial. These patients will serve as our control group population. Detailed medical history will be collected and the study group patients will be asked to complete two questionnaire to assess the severity of the symptoms. They will be followed in the clinic at 6, 12, 18 and 24 months post implantation.

Eligibility

Inclusion Criteria Study Group:

        Patients who are undergoing surgical full-thickness biopsy of the stomach and/or proximal
        jejunum for the clinical evaluation of GI neuromuscular disorder.
        Inclusion Criteria Control Group:
        Patients undergoing esophagectomy, sleeve gastrectomy for obesity, or Roux-en Y gastric
        bypass Patients undergoing Whipple surgery Patients undergoing transplant surgery
        Patients who are organ donors and undergoing surgery
        Exclusion Criteria Study Group:
        Contraindication for surgical full-thickness biopsy for any reason. Significant comorbidity
        due to severe cardiovascular, renal, pulmonary, or liver disease.
        Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident.
        Pregnant Unable to give own informed consent Prisoners
        Exclusion Criteria Control Group:
        Prior diagnosis of gastroparesis Prior diagnosis of chronic intestinal pseudo-obstruction
        Unable to give own informed consent if not an organ donor

Study details
    Gastroparesis

NCT02165059

Indiana University

26 January 2024

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