Treatment of Reflux With Sleeve Gastrectomy

Preventing and Treating Reflux With Cruroplasty and Omentopexy After Laparoscopic Sleeve Gastrectomy

In 2008, the World Health Organization (WHO) report found that 0.5-1.5 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 2.3 and 0.7 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 and/or 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hiatal Hernia; Reflux Esophagitis; Reflux Disease, Gastro-Esophageal
• Intervention / Treatment: Other: Laparoscopic Sleeve Gastrectomy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Küçükçekmece, İstanbul, Turkey, 34295
      • Istanbul Aydin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Obesity,

Exclusion Criteria:

• Eating disorder or mental disorder
• Misunderstanding of the protocol
• Psychiatric contraindication
• Patient participating in another interventional clinical research protocol involving a drug or medical device
• Pregnant, breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Sleeve Gastrectomy	Other: Laparoscopic Sleeve Gastrectomy; Laparoscopic sleeve gastrectomy (LSG) is a surgical procedure widely used in the treatment of obesity. It's a bariatric procedure, meaning its primary aim is to induce weight loss, and it has gained popularity due to its effectiveness and relatively low complication rates compared to other bariatric surgeries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Gastroesophageal Reflux Disease Health-Related Quality of Life Survey	12 months

Collaborators and Investigators

• Sponsor: Yusuf Emre ALTUNDAL

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Gastroesophageal Reflux; Esophagitis, Peptic; Hernia, Hiatal; Esophagitis
• Other Study ID Numbers: IAU-YUSUFEMREALTUNDAL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No