Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04166461
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2019-11-14
Brief Title:
Mucosal Impedance Sleeve Gastrectomy
Sponsor:
MetroHealth Medical Center
Organization:
MetroHealth Medical Center
Study Overview
Official Title:
Assessment of Esophageal Mucosal Impedance Before and After Sleeve Gastrectomy
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals Studies have demonstrated that after LSG between 5 and 30 of patients suffered from GERD with a small subset of those patients 29 converting to another bariatric procedure gastric bypass because of debilitating GERD symptoms
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure as well as assess quality of life and GERD symptoms parameters In addition this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD
This is a prospective comparative cohort study A total of 15 obese patients BMI 35 undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation during which mucosal impedance will be performed with the consent of the patient Patients with evidence of erosive esophagitis LA grade A-D Barretts esophagus or eosinophilic esophagitis will be excluded from the study As per surgical recommendation PPI will be used for 6 months in all bariatric patients
Six months post-surgery study patients will be re-evaluated by the GERD symptoms Checklist and SF 36 In addition their new BMI will be documented PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barretts esophagus In addition esophageal mucosal impedance will be reassessed
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure as well as assess quality of life and GERD symptoms parameters In addition this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD
This is a prospective comparative cohort study A total of 15 obese patients BMI 35 undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation during which mucosal impedance will be performed with the consent of the patient Patients with evidence of erosive esophagitis LA grade A-D Barretts esophagus or eosinophilic esophagitis will be excluded from the study As per surgical recommendation PPI will be used for 6 months in all bariatric patients
Six months post-surgery study patients will be re-evaluated by the GERD symptoms Checklist and SF 36 In addition their new BMI will be documented PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barretts esophagus In addition esophageal mucosal impedance will be reassessed
Detailed Description:
RationaleSignificance
Obesity is a growing epidemic problem around the world World Health Organization WHO defines obesity as a body mass index BMI over 30 Kgm2 and it is estimated that 10 of the worlds population is obese Associated with obesity are health conditions that carry significant morbidity and mortality including cardiovascular disease osteoarthritis diabetes cancer breast colon and endometrial and gastroesophageal reflux disease GERD Bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals
As part of their limited GI workup candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery However no studies are preferred to assess the degree of esophageal acid exposure in patients with normal endoscopy who are candidates for LSG In addition there is no routine assessment of patients post LSG for the development of GERD
The effect of laparoscopic sleeve gastrectomy LSG on GERD has been equivocal with low-quality evidence suggesting both improvement and worsening of reflux after surgery Studies have demonstrated that after LSG between 5 and 30 of patients suffered from GERD with a small subset of those patients 29 converting to another bariatric procedure gastric bypass because of debilitating GERD symptoms
As part of their limited GI workup candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery Currently there is no routine formal endoscopic or pH assessment of patients after gastric weight loss surgery for the development of GERD The effect of laparoscopic sleeve gastrectomy LSG on GERD has been equivocal with low-quality evidence from various studies suggesting both improvement and worsening of reflux after surgery
The main purpose of this study is to evaluate whether GERD develops after LSG and to examine the esophagus after LSG for the possible development of acid reflux both endoscopically visible by camera view and on a cellular level by obtaining mucosal impedance Mucosal impedance MI is a measurement that can evaluate if the structure of the esophageal tissue is normal or abnormal MI is performed using an FDA approved endoscopic tool called Mucosal Integrity Conductivity Test System Diversatek The MI system software uses the collected data to determine if there is evidence of GERD
Objective
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure as well as assess quality of life and GERD symptoms parameters In addition this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD
This is a prospective comparative cohort study A total of 15 obese patients BMI 35 undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation during which mucosal impedance will be performed with the consent of the patient Patients with evidence of erosive esophagitis LA grade A-D Barretts esophagus or eosinophilic esophagitis will be excluded from the study As per surgical recommendation PPI will be used for 6 months in all bariatric patients
Six months post-surgery study patients will be re-evaluated by the GERD symptoms Checklist and SF 36 In addition their new BMI will be documented PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barretts esophagus In addition esophageal mucosal impedance will be reassessed
Primary aim
- To determine the development of GERD after sleeve gastrectomy by measuring esophageal mucosal impedance pre and post-surgery
Secondary aim
To determine the degree of GERD development post sleeve gastrectomy
To determine any effect on quality of life post-sleeve gastrectomy
Obesity is a growing epidemic problem around the world World Health Organization WHO defines obesity as a body mass index BMI over 30 Kgm2 and it is estimated that 10 of the worlds population is obese Associated with obesity are health conditions that carry significant morbidity and mortality including cardiovascular disease osteoarthritis diabetes cancer breast colon and endometrial and gastroesophageal reflux disease GERD Bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals
As part of their limited GI workup candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery However no studies are preferred to assess the degree of esophageal acid exposure in patients with normal endoscopy who are candidates for LSG In addition there is no routine assessment of patients post LSG for the development of GERD
The effect of laparoscopic sleeve gastrectomy LSG on GERD has been equivocal with low-quality evidence suggesting both improvement and worsening of reflux after surgery Studies have demonstrated that after LSG between 5 and 30 of patients suffered from GERD with a small subset of those patients 29 converting to another bariatric procedure gastric bypass because of debilitating GERD symptoms
As part of their limited GI workup candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery Currently there is no routine formal endoscopic or pH assessment of patients after gastric weight loss surgery for the development of GERD The effect of laparoscopic sleeve gastrectomy LSG on GERD has been equivocal with low-quality evidence from various studies suggesting both improvement and worsening of reflux after surgery
The main purpose of this study is to evaluate whether GERD develops after LSG and to examine the esophagus after LSG for the possible development of acid reflux both endoscopically visible by camera view and on a cellular level by obtaining mucosal impedance Mucosal impedance MI is a measurement that can evaluate if the structure of the esophageal tissue is normal or abnormal MI is performed using an FDA approved endoscopic tool called Mucosal Integrity Conductivity Test System Diversatek The MI system software uses the collected data to determine if there is evidence of GERD
Objective
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure as well as assess quality of life and GERD symptoms parameters In addition this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD
This is a prospective comparative cohort study A total of 15 obese patients BMI 35 undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation during which mucosal impedance will be performed with the consent of the patient Patients with evidence of erosive esophagitis LA grade A-D Barretts esophagus or eosinophilic esophagitis will be excluded from the study As per surgical recommendation PPI will be used for 6 months in all bariatric patients
Six months post-surgery study patients will be re-evaluated by the GERD symptoms Checklist and SF 36 In addition their new BMI will be documented PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barretts esophagus In addition esophageal mucosal impedance will be reassessed
Primary aim
- To determine the development of GERD after sleeve gastrectomy by measuring esophageal mucosal impedance pre and post-surgery
Secondary aim
To determine the degree of GERD development post sleeve gastrectomy
To determine any effect on quality of life post-sleeve gastrectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None