Innovations in General and Gastrointestinal Surgery at Ohio State

Innovations The Division of General and Gastrointestinal Surgery continues to successfully grow its clinical research portfolio year over year. Our faculty members are trained experts in minimally invasive surgery who share a focus to better understand outcomes of current practices while pursuing opportunities to investigate those that will influence the future of medicine. Our profile maintains three surgical areas of disease concentration – Foregut, Abdominal Core Health (including hernia), and Bariatrics – that span various topics including clinical outcomes, innovation, education, and patient access models.

The Division of General and Gastrointestinal Surgery is also active in several collaborative research efforts across The Ohio State Wexner Medical Center and University while serving as home to accomplished translational science researchers who explore the functions behind wound angiogenesis and healing.

Toward Opioid-Free Ambulatory Surgery (TOFAS)

TOFAS is a study led by The Ohio State University Wexner Medical Center’s Division of General and Gastrointestinal Surgery and funded by the Care Innovation and Community Improvement Program to investigate the effectiveness of pain management without opioids for same-day or ambulatory surgery patients.

The Center for Surgical Health Assessment, Research, and Policy (SHARP)

Under the direction of Heena Santry, Vice Chair for Health Services Research, SHARP provides resources for faculty to pursue high-impact, high-quality health services research by linking multidisciplinary members through shared interests and goals.

Highlighted Clinical Trials by Specialty

A Post-Approval Study of the LINX® Reflux Management System Foregut

LINX

This is a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the LINX implant procedure and device for the treatment of gastroesophageal reflux disease (GERD). This study is being done in an FDA post-approval environment to supplement existing safety and efficacy data. Patients are followed for up to ten years following implantation.

Kyle Perry, MD is our site principal investigator for this trial. Dr. Perry also participated in the pre-FDA approval trial for the LINX device and has 10+ years of experience performing the LINX operation.
A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD) Foregut

EndoStim

The purpose of this investigation is to demonstrate the safety and effectiveness of a Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects are randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation. This is a pre-FDA approval investigation.

Kyle Perry, MD is our site principal investigator for this trial. Dr. Perry has extensive experience participating in trials that investigate innovative technologies with the potential to accommodate patient preference and achieve desired outcomes.
Parietene™ DS Composite Mesh in Ventral Hernia Repair Clinical Study Hernia

Parietene™ DS Composite Mesh

This is a multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair. The purpose of this research is to confirm the safety and performance of the Parietene™ DS Composite Mesh, in the short (1, 3 months), mid (1 year) and the long term (2 years).

Vimal Narula, MD is our site principal investigator for this trial. Dr. Narula’s research interests include hernia repair, minimally invasive surgery, surgical endoscopy, and biliary disease.
TAP Blocks for Robotic Inguinal Hernia Repair Hernia

TAP Blocks

This study is an investigator-initiated, randomized, double-blinded trial to evaluate the effectiveness of transverse abdominis plane (TAP) blocks on postoperative pain after robotic-assisted inguinal hernia repairs. The primary outcome of interest is the reduction of post-surgical opioid use and dependency.

David Renton, MD is the co-principal investigator in collaboration with Michael Kushelev, MD (Department of Anesthesia). Dr. Renton specializes in minimally invasive abdominal surgery, including hernia, foregut, and biliary disease.
Stomach Intestinal Pylorus Sparing (SIPS) as a Primary and Revisional Bariatric Surgery Bariatrics

SIPS

This is an investigator-initiated trial to study the safety and efficacy of the Stomach Intestinal Pylorus Sparing Surgery (SIPS). SIPS is an exciting, relatively new option for bariatric surgery that offers the advantages of successful weight loss and resolution of comorbid conditions observed after more commonly performed procedures (Roux-en-Y gastric bypass & Sleeve Gastectomy) while potentially reducing the risk of marginal ulceration and dumping syndrome.

Brad Needleman, MD is the principal investigator for this trial in addition to serving as Medical Director for the Comprehensive Weight Management & Bariatric Surgery Center, Director of the Center for Minimally Invasive Surgery, and Vice Chair of Strategy and Clinical Operations for the Department of Surgery. Dr. Needleman’s professional interests are to provide the right operation for the right patient with life-long care to optimize results. In this pursuit, Dr. Needleman observed and trained with the founders of the SIPS procedure before committing to performing the procedure himself.
Reducing Barriers to Care after Bariatric Surgery for Medicaid Patients and Patients with Disabilities on Medicare Using an Outpatient Bariatric Care Coach Bariatrics

Reducing Barriers

This is an investigator-initiated study that utilizes mixed-methodology to elucidate existing barriers to care for Medicaid and Medicare patients undergoing bariatric surgery. The findings of this study will serve to create new patient care models that will optimize patient experience and outcomes.

Sabrena Noria, MD,PhD is the principal investigator for this study and has been awarded a $290,960 grant to carry out this project. As a bariatric surgeon, Dr. Noria encourages her patients to take an active role in improving their health, while reassuring them along the way. Through this project, Dr. Noria will identify the tools her patient population needs to succeed so that she can offer them the greatest opportunities for success.

Basic and Translational Science

Novel Nanoscale Approaches to Whole Tissue Reprogramming

Novel NanoscaleBas

This study aims to develop tissue nano-transfection (TNT)-based strategies to come up with innovative ways to deliver gene and/or cell therapies to nerve tissue both at the peripheral and central nervous system level.

Daniel Gallego-Perez, PhD is a biomedical engineering assistant professor who continues his research through a recently awarded National Institutes of Health (NIH) Director’s New Innovator Award with a support of $2.3 million.

Highlighted Collaborative Clinical Trials

Effect of Genetic Variations on Successful Post Bariatric Surgery Outcomes
Relative Contributions of Obesity and Smoking to the Oral Microbiome
The Colorectal Cancer Risk Paradox After Roux-en-Y Gastric Bypass Surgery and Weight Regain: Interplay and Mechanistic Insights into the Role of Gut Microbiome and Lipidomics
Effect of Adiposity Changes on Endometrial Tissue and Blood Biomarkers
A Prospective Randomized Open-Label Trial Investigating the Effect of Sugammadex versus Neostigmine during Neuromuscular Blockade Reversal in Outpatient Surgeries – An Evaluation of Clinical and Associated Health Care Cost

General and Gastrointestinal Surgery Research

Innovations in General and Gastrointestinal Surgery at Ohio State

Toward Opioid-Free Ambulatory Surgery (TOFAS)

The Center for Surgical Health Assessment, Research, and Policy (SHARP)

Highlighted Clinical Trials by Specialty

A Post-Approval Study of the LINX® Reflux Management System Foregut

A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD) Foregut

Parietene™ DS Composite Mesh in Ventral Hernia Repair Clinical Study Hernia

TAP Blocks for Robotic Inguinal Hernia Repair Hernia

Stomach Intestinal Pylorus Sparing (SIPS) as a Primary and Revisional Bariatric Surgery Bariatrics

Reducing Barriers to Care after Bariatric Surgery for Medicaid Patients and Patients with Disabilities on Medicare Using an Outpatient Bariatric Care Coach Bariatrics

Basic and Translational Science

Novel Nanoscale Approaches to Whole Tissue Reprogramming

Highlighted Collaborative Clinical Trials

Effect of Genetic Variations on Successful Post Bariatric Surgery Outcomes

Relative Contributions of Obesity and Smoking to the Oral Microbiome

The Colorectal Cancer Risk Paradox After Roux-en-Y Gastric Bypass Surgery and Weight Regain: Interplay and Mechanistic Insights into the Role of Gut Microbiome and Lipidomics

Effect of Adiposity Changes on Endometrial Tissue and Blood Biomarkers

A Prospective Randomized Open-Label Trial Investigating the Effect of Sugammadex versus Neostigmine during Neuromuscular Blockade Reversal in Outpatient Surgeries – An Evaluation of Clinical and Associated Health Care Cost

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