GI Neuromuscular Pathology Prospective Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any - 90 |
| Updated: | 10/15/2017 |
| Start Date: | December 2013 |
| End Date: | December 2020 |
| Contact: | Anita Gupta, MBBS, MPH |
| Email: | anigupta@iu.edu |
| Phone: | 317-948-9227 |
Indiana University GI Neuromuscular Pathology Prospective Registry
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).
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).
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.
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.
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
We found this trial at
1
site
600 University Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Phone: 317-948-9227
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