Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-06
Brief Title:
Treatment of Reflux With Sleeve Gastrectomy
Sponsor:
Yusuf Emre ALTUNDAL
Organization:
Istanbul Aydın University
Study Overview
Official Title:
Preventing and Treating Reflux With Cruroplasty and Omentopexy After Laparoscopic Sleeve Gastrectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
In 2008 the World Health Organization WHO report found that 05-15 billion people aged 20 years and above suffer from overweight body mass index BMI 25 and obesity BMI 30 kg m2 stated
WHO estimates that the number of overweight and obese people will reach 23 and 07 billion respectively by 2045
Bariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity The most common type of bariatric surgery against obesity is Laparoscopic Sleeve Gastrectomy LSG
As after any surgical operation complications may occur after Laparoscopic Sleeve Gastrectomy Additional operations may be required to correct complications such as bleeding anastomotic leak gastric volvulus infection dyspepsia hiatal hernia bile andor acid reflux
The incidence of gastroesophageal reflux disease GERD is significantly increased in obese patients compared to the incidence in normal individuals Various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure esophageal motility disorders especially hypotensive lower esophageal sphincter pressure 10 mm Hg finally the development of hiatal hernia HH whose prevalence in the obese population is significantly higher than in non-obese patients
Various surgical methods have been presented to prevent postoperative de-novo Gastroesophageal Reflux and de-novo Hiatal Hernia that occur after LSG Curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative GERD and Hiatal Hernia
In this surgical technique after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter LES the hiatal hernia if present is reduced into the abdomen Afterwards Z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough In this way it is aimed to strengthen the diaphragmatic crus Findings following cruroplasty for GERD prevention are varied Although some authors state that the technique does not provide an advantage in preventing postoperative GERD some studies have shown cruroplasty to be effective
In this study investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with LSG is a treatment for GERD and HH which are very common in obese patients and a preventive technique for de-novo GERD seen after LSG
WHO estimates that the number of overweight and obese people will reach 23 and 07 billion respectively by 2045
Bariatric surgery has been developed in response to the number of obese patients living in the world and the complications caused by obesity The most common type of bariatric surgery against obesity is Laparoscopic Sleeve Gastrectomy LSG
As after any surgical operation complications may occur after Laparoscopic Sleeve Gastrectomy Additional operations may be required to correct complications such as bleeding anastomotic leak gastric volvulus infection dyspepsia hiatal hernia bile andor acid reflux
The incidence of gastroesophageal reflux disease GERD is significantly increased in obese patients compared to the incidence in normal individuals Various studies have shown that obesity causes delayed gastric emptying due to increased abdominal pressure esophageal motility disorders especially hypotensive lower esophageal sphincter pressure 10 mm Hg finally the development of hiatal hernia HH whose prevalence in the obese population is significantly higher than in non-obese patients
Various surgical methods have been presented to prevent postoperative de-novo Gastroesophageal Reflux and de-novo Hiatal Hernia that occur after LSG Curorrhaphy is one of these techniques that is accepted to prevent the formation or exacerbation of postoperative GERD and Hiatal Hernia
In this surgical technique after the diaphragmatic crura are completely exposed at the level of the lower esophageal sphincter LES the hiatal hernia if present is reduced into the abdomen Afterwards Z surgical sutures are applied to the diaphragmatic crura to make the diaphragmatic esophageal ring narrow enough In this way it is aimed to strengthen the diaphragmatic crus Findings following cruroplasty for GERD prevention are varied Although some authors state that the technique does not provide an advantage in preventing postoperative GERD some studies have shown cruroplasty to be effective
In this study investigators aimed to show that the technique of simultaneous cruroplasty and single suture omentopexy with LSG is a treatment for GERD and HH which are very common in obese patients and a preventive technique for de-novo GERD seen after LSG
Detailed Description:
None
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