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NCT Number: NCT07349732

Ligamentum Teres Cardiopexy in Treatment of GERD After Sleeve Gastrectomy

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

  • Sectioning the gastric fundus leaves the upper esophagus open when the food passes and changes the angle of His from 36° to 51
  • Damaging the sling fibers, cutting the noose that forms the LES, and promoting GERD
  • Augmented intragastric pressure, confirmed by manometry, increases the gastroesophageal pressure gradient and reflux
  • 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)
  • Vagal nerve injury
  • Poor surgical technique leads to twisting, kinking, or strictures of the gastric tube.
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ligamentum teres cardiopexy

Procedure

ligamentum ters cardiopexy in tratment of GERD in post sleeve gastrectomy

Primary outcomes

  1. Improvement in GERD symptoms at 6-month and 12-month follow-up.

    Time frame: 12 month

    Development and evaluation of FSSG: frequency scale for the symptoms of GERD

Sponsors and collaborators

Lead sponsor

Andrew Mokbel

Other

Registry information

Official study title

Comparative Study Between Ligamentum Teres Cardiopexy and Gastric Bypass in Treatment of Post Sleeve Gastrectomy GERD

Acronym: GERD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.