Achalasia, Gastric Fistula, Gastric Nec, Marginal Ulcer, Stenoses, Weight Gain After Primary Weight Loss Surgery
Conditions
Keywords
Achalasia, Fistula, Obesity, POEM, GERD, endoscopic, treatments, post bariatric surger weight gain, endoluminal, Bariatric Surgery, Barretts
Brief summary
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.
Detailed description
Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.
Interventions
PROCEDUREEndoscopic Intervention
After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult male and female patients 18-80 years of age * Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s) * Gastrointestinal Reflux Disease * Achalasia * Barrett's Esophagus * Post Bariatric Surgery conditions * Other gastrointestinal and postsurgical disorders.
Exclusion criteria
* Adults unable to consent * Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in GERDDQ | 3-6 months | Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Eckardt scoring | 30 days | Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0) |
Countries
United States
Outcome results
None listed