Outcome Analysis of POEM and Endoluminal Therapies

Study Overview
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Brief Summary
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Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Detailed Description
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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.

Official Title
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Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms

Conditions
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Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery, Marginal Ulcer, Stenoses, Gastric Nec

Intervention / Treatment
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* Procedure: Endoscopic Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples. | Procedure: Endoscopic Intervention<br>* 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.<br>* Other names: Endoluminal Therapies, POEM, Endoscopic Revision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in GERDDQ | Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5) | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Eckardt scoring | Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achalasia, Fistula, Obesity, POEM, GERD, endoscopic, treatments, post bariatric surger weight gain, endoluminal, Bariatric Surgery, Barretts