Ligamentum Teres Cardiopexy in Treatment of GERD After Sleeve Gastrectomy (GERD)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Effect of Ligamentum Teres in Hiatus Hernia
• Intervention / Treatment: Procedure: ligamentum teres cardiopexy

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Assuit University Hospital
    • Contact: Andrew mokbel sawers, assistant lecture; Phone Number: +2001090981160; Email: andrew.sawers55@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

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

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
Other: ligamentum teres cardiopexy; will do ligamentum teres cardiopexy in treatment of GERD	Procedure: ligamentum teres cardiopexy; ligamentum ters cardiopexy in tratment of GERD in post sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in GERD symptoms at 6-month and 12-month follow-up.	Development and evaluation of FSSG: frequency scale for the symptoms of GERD	12 month

Collaborators and Investigators

• Sponsor: Andrew Mokbel

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ligamentum teres cardiopexy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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