Effect of Ligamentum Teres in Hiatus HerniaGERDNCT07349732
Ligamentum Teres Cardiopexy in Treatment of GERD After Sleeve Gastrectomy
A study testing ligamentum teres cardiopexy in people with Effect of Ligamentum Teres in Hiatus Hernia, run by Andrew Mokbel at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Effect of Ligamentum Teres in Hiatus Hernia
- What is being tested?
- ligamentum teres cardiopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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 )
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assuit University Hospital
Asyut
Andrew mokbel sawers, assistant lecture, +2001090981160, andrew.sawers55@gmail.com
About this study
Official title: 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
Read the 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
- 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).
- Being tested
- ligamentum teres cardiopexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ligamentum teres cardiopexyProcedure or surgery
ligamentum ters cardiopexy in tratment of GERD in post sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| ligamentum teres cardiopexy | Other | will do ligamentum teres cardiopexy in treatment of GERD Receives: Procedure: ligamentum teres cardiopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in GERD symptoms at 6-month and 12-month follow-up.
Development and evaluation of FSSG: frequency scale for the symptoms of GERD
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Ligamentum Teres in Hiatus HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Mokbel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Mokbel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349732
- Sponsor's protocol ID
- ligamentum teres cardiopexy
- Acronym
- GERD
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ligamentum Teres Cardiopexy and Gastric Bypass in Treatment of Post Sleeve Gastrectomy GERD
- ClinicalTrials.gov ID
- NCT07349732
- Acronym / sponsor ID
- GERD / ligamentum teres cardiopexy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Andrew MokbelUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ligamentum teres cardiopexy | Other | Procedure: ligamentum teres cardiopexywill do ligamentum teres cardiopexy in treatment of GERD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • patients who previously underwent laparoscopic sleeve gastrectomy
Key exclusion criteria (3 listed)
- • Known esophageal motility disorders (achalasia, scleroderma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ligamentum teres cardiopexyligamentum ters cardiopexy in tratment of GERD in post sleeve gastrectomy | Procedure or surgery | ligamentum teres cardiopexy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ligamentum teres cardiopexy in people with Effect of Ligamentum Teres in Hiatus Hernia, run by Andrew Mokbel at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in GERD symptoms at 6-month and 12-month follow-up. (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.