In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Gastroparesis

Transpyloric stent

Sham

Northwestern University

Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis

Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: A Prospective Sham Study

GCSI assessment is based off an average of 16 questions that are scored from 0-5, with higher scores indicating a worse clinical outcome.

Assessed based on current American Society for Gastrointestinal Endoscopy (ASGE) guideline definitions for endoscopic adverse events

A. Aziz Aadam

Assistant Professor

Participants and other care providers are blinded to whether they receive a transpyloric stent vs sham

Intraoperative laparoscopic intramuscular injection of 100units (10cc) of Botulinum toxin into the pylorus

Intraoperative laparoscopic intramuscular injection of 10cc normal saline into the pylorus

Bariatric Surgery

Postoperative Nausea and Vomiting

Intraoperative laparoscopic injection of Botulinum toxin into the pylorus immediately following sleeve gastrectomy

Botulinum toxin pyloroplasty

Intraoperative laparoscopic injection of normal saline into the pylorus immediately following sleeve gastrectomy

Normal saline pyloric injection

Albany Medical Center

Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy

We will sum the number of "as needed" doses of intravenous antiemetics required by patients in both the treatment arm and the control arm of the study

Likert scales describing overall satisfaction with postoperative course

Likert score rating subjective experience of nausea

Jessica Zaman

Assistant Professor of Surgery

Albany Medical College

Allergan

Participants with refractory gastroparesis will be confirmed by endoscopy, clinical and scintigraphy studies.

Gastroparesis Postoperative

Gastroparesis Due to Diabetes Mellitus

Idiopathic Gastric Stasis

After confirmation of refractory gastroparesis, participants will undergo to gastric POEM. Participants will be admitted to hospital 24hrs before procedure and IV antibiotics will be given and then the procedure will be done. Technique consist of 4 steps: First: a submucosa injection of saline solution with methylene blue at 3-4cms from pylorus. Second: a submucosa incision and tunnel creation up to pyloric area. Third: Myotomy of the circular and longitudinal muscular layers of the pylorus and the antrum. Fourth: closure of the mucosal incision with hemoclips. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic and scintigraphic studies up to 1 year after procedure.

G-POEM

Centro Medico Nacional Siglo XXI Hospital de Especialidades

Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

Safety and Efficacy of Gastric Per Oral Endoscopic Myotomy (G-POEM) in Patients With Refractory Gastroparesis

The investigators will compare the percentage of improvement in scintigraphy before and after procedure

measured as the presence of complications during or after procedure

Coordinación de Investigación en Salud, Mexico

This a prospective study that evaluates G-POEM in a group of participants with diagnosis of refractory gastroparesis. Participants are sequentially recruited as diagnosed.

MOVANTIK™ (Naloxegol) 25 mg oral capsule, daily

Opioid-Induced Disorders

Esophagus Disorder

Naloxegol

Placebo Oral Capsule

Temple University

Movantik for Opioid-Related Esophageal Disorders

The effect of MOVANTIK™ (Naloxegol) on motor function, categorized as a 25% (mmHg) improvement in IRP (Integrated Relaxation Pressure) on high resolution esophageal manometry from baseline to visit three, comparing study group to placebo control group.

Mean change from baseline to visit three in subject esophageal symptom scores according to the PAGI-SYM.

Mean change from baseline to visit three in subject esophageal symptom scores according to the McGill pain inventory.

Mean change from baseline to visit three in subject esophageal symptom scores according to the GERD symptom check list.

Mean change from baseline to visit three in subject esophageal symptom scores according to the chest pain symptom questionnaire.

Mean change from baseline to visit three in subject esophageal symptom scores according to the daily diary

The occurrence of adverse events and early withdrawal in study group when compared to placebo control group to determine safety and tolerability.

Mean change in patient-reported quality of life according to the SF-36

AstraZeneca

Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.

Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.

Reletex plus scheduled ondansetron and phenergan prn

Reletex

Control

Total

Sex: Female, Male

Region of Enrollment

Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.

Quantify the Amounts of Phenergan Used Between the Two Groups.

Overall Study

Kyle A. Perry, MD

Nausea and Vomiting Post-foregut Surgery

Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.

IV ondansetron 4 mg q 6 hours for a total of 4 doses

IV promethazine 25 mg q 6 hours prn

Elixir promethazine 25 mg q 6 hours prn after discharge

The Ohio State University Medical Center

Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery

Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial

esophageal achalasia/pykinimas

Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis

Botulinum Toxin Pyloroplasty to Reduce Postoperative Nausea and Vomiting After Sleeve Gastrectomy

Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

Movantik for Opioid-Related Esophageal Disorders

Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery

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