Ligamentum Teres Cardiopexy in Treatment of GERD After Sleeve Gastrectomy

Andrew Mokbel

Status: Not yet enrolling

Conditions: Effect of Ligamentum Teres in Hiatus Hernia

Treatments: Procedure: ligamentum teres cardiopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT07349732

ligamentum teres cardiopexy

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness and safety of surgical repair techniques with ligamentum teres cardiopexy on symptomatic relief of gastroesophageal reflux disease (GERD), recurrence rates of hiatus hernia, and overall patient quality of life following sleeve gastrectomy

Full description

Laparoscopic sleeve gastrectomy (LSG) has become one of the most commonly performed bariatric procedures worldwide due to its effectiveness in achieving sustained weight loss and improving obesity-related comorbidities. However, it is increasingly recognized that LSG may lead to or exacerbate gastroesophageal reflux disease (GERD) and contribute to the development or worsening of hiatus hernia (HH). GERD incidence after LSG has been reported to range from 20% to 60%, making it a significant postoperative complication impacting patient quality of life. The underlying pathophysiology involves changes in gastroesophageal anatomy and physiology following the resection of the gastric fundus and alteration of the lower esophageal sphincter pressure, along with increased intragastric pressure due to the sleeve's tubular shape Changes after a sleeve gastrectomy

1. Sectioning the gastric fundus leaves the upper esophagus open when the food passes and changes the angle of His from 36° to 51
2. Damaging the sling fibers, cutting the noose that forms the LES, and promoting GERD
3. Augmented intragastric pressure, confirmed by manometry, increases the gastroesophageal pressure gradient and reflux
4. Herniation of the gastric tube into the thoracic cavity, disarming the associated gastro and esophagus-phrenic ligaments, leaving the pouch with a greater capacity to suffer from the pressures applied by the stomach and thorax, which may produce a hiatal hernia (HH)
5. Vagal nerve injury
6. Poor surgical technique leads to twisting, kinking, or strictures of the gastric tube.
7. A dynamic pylorus When Surgery Is Considered

After SG, most patients with GERD are first managed with lifestyle changes and medical therapy (e.g. PPIs). Surgery or more invasive interventions are considered when:

1. GERD symptoms are refractory despite maximal medical treatment.
2. There are anatomical problems contributing to reflux, e.g. hiatal hernia, sleeve twist, stenosis, sleeve dilation, intrathoracic migration of the sleeve.
3. There's also insufficient weight loss or weight regain (so revisional surgery may serve dual purposes).

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • patients who previously underwent laparoscopic sleeve gastrectomy

  • Adequate anatomy to perform the procedure For example, ability to mobilize adequate intra-abdominal esophagus (e.g. freeing 3-5 cm of esophagus into abdomen) and enough ligamentum teres tissue to wrap/fix
  • Patients experiencing GERD symptoms refractory to medical therapy (e.g., proton pump inhibitors more than 8 weeks )

Exclusion criteria

• • Known esophageal motility disorders (achalasia, scleroderma).

  • Barrett's esophagus with high grade dysplasia
  • Presence of complications contraindicating the use of ligamentum teres For example, prior surgeries that compromised ligamentum teres, hepatic disease, malignancy near ligament region

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

ligamentum teres cardiopexy

Other group

Description:

will do ligamentum teres cardiopexy in treatment of GERD

Treatment:

Procedure: ligamentum teres cardiopexy