AzTrials
AzTrials

Hiatus HerniaNCT07251010

Phrenoesophageal Ligament Reconstruction With Mesh

A study testing Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) and Classic approach in people with Hiatus Hernia and Gastreoesophageal Reflux Disease, run by Clinical Trial Aseer at 2 sites in Saudi Arabia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Introduction: The phrenoesophageal ligament (PEL) is a crucial structure that attaches the esophagus to the diaphragm, allowing for independent movement during respiration and swallowing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) and Classic approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSaudi Arabia
Study dates
1 Mar 2026to 31 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (≥18 years)
  • Symptomatic hiatus hernia
  • Primary hiatus hernia
  • Not responding to medical treatment

Who cannot join

  • Children (<18 years)
  • Recurrent hiatus hernia
  • Post-bariatric surgery
  • Pregnancy
  • Crohn's disease
  • Emergency surgery cases

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ali Nasser AlQahtani contact

+966558015206

dr.alinasser@windowslive.com

Saudi Arabia2 sites, 2 recruiting
  • Asser Health Cluster

    Abhā, 'Asir Region, 62521

    Ali Nasser Alqahtani, +966558015206, aalqahtani174@moh.gov.sa

    Not yet recruiting
  • Aseer central hospital

    Abhā, 'Asir Region

    Dr.Ali Nasser, MBBS.SBGS, 00966558015206, Aalqahtani174@moh.gov.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Phrenoesophageal Ligament Reconstruction With Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) for Adult Patients With Symptomatic Hiatus Hernia: A Randomized Controlled Trial

Introduction: The phrenoesophageal ligament (PEL) is a crucial structure that attaches the esophagus to the diaphragm, allowing for independent movement during respiration and swallowing. The ligament provides flexibility and strength, maintaining the integrity of the esophageal hiatus while accommodating pressure changes during breathing and swallowing. It consists of two limbs. The upper limb attaches the esophagus to the superior surface of the diaphragm, extending through the hiatus t'o insert into the esophagus 2-3 cm above it. The Lower Limb attaches the cardiac region of the stomach to the inferior surface of the diaphragm at the cardiac notch of the stomach. Failure and weakness of the PEL can predispose to esophageal HH and GERD symptoms. Understanding its anatomy is essential for the surgical management of hiatal hernia and GERD.

Purpose: To investigate the effectiveness and safety of a new technique for hiatal hernia repair (Alinasser's Technique of LHHR) using a mesh fixed to both the esophagus and crura, mimicking PEL, with a focus on reducing recurrence rates and improving patient outcomes. Methods: A randomized controlled trial study will be followed. The study will include 60 HH patients who will be randomized into either the intervention group (30 patients) who will undergo the new approach, or the classic group (30 patients) who will undergo the classic approach. Patients in the intervention group will undergo cruroplasty using a new technique (mesh applied like PEL). Importance: A new surgical technique is being applied for management of HH to decrease postoperative recurrence

Read the detailed description

Diagnosis of GERD, esophagitis, and hiatus hernia:

Preoperative diagnosis We will use the GERD-Health-Related Quality of Life (GERD-HRQL) questionnaire to evaluate symptoms of GERD [11]. Preoperative assessment to diagnose HH by upper GIT endoscopy and a barium meal test in reverse Trendelenburg position. The Los Angeles system will be used for grading esophagitis [12]. 24 pH and esophageal manometry will be used to assess the esophageal motility and esophageal PH

Surgical technique:

Under general anaesthesia, Alinasser's Technique of LHHR will be carried out in the Frensh position. The pneumoperitoneum was created with CO2 pressures as high as 15 mmHg.

Procedure Position. The patient is positioned the French position, the surgeon stands in-between the legs and the assistants stand on either side of the patient, Steep reverse Trendelenburg positioning is often required. Port placement. We use a standard ports placement for most foregut procedures performed.

This consists of establishment of pneumo-peritoneum using a Veress needle placed at Palmer's point in the left upper abdomen. An 10-mm optical trocar is inserted in the left subcostal position.

Additional ports are placed under direct vision as follows (Figure 1):

  • Camera port (10 mm) in epigastric position (midway between the xiphoid process and the umbilicus.
  • Assistant (5 mm) port at the left anterior axillary line below the costal margin.
  • Surgeon's left hand port (5 mm) in right upper quadrant at the midclavicular line.
  1. Expose the diaphragmatic hiatus by retracting the left lateral segment of the liver.
  2. Reduce stomach and hiatal hernia sac by mobilizing the gastric fundus. Dissection begins with takedown of short gastric vessels and proceeds toward the diaphragmatic hiatus to fully expose the left diaphragmatic crus.
  3. Complete circumferential dissection of the hiatal hernia sac at the level of diaphragmatic hiatus. It is often easiest to gain entry into the proper plane immediately adjacent to the left crus. The correct plane is bloodless and involves division of loose areolar attachments. The right crus is approached by dividing the pars flaccida and dissected until the left crus is visualized. It is important to preserve the integrity of the crura during this phase of the dissection.
  4. The mediastinal dissection continues in a cranial direction to obtain enough intraabdominal esophageal length (minimum 3-5 cm).
  5. A non-absorbable mesh (≈2.0 x 10.0 cm) is sutured to the esophagus, just above the hiatus by four 2-0 prolene stitches. The continuity of the mesh is then fixed just below the hiatus anteriorly on the diaphragm by four 2-0 prolene stitches. About half of the mesh is fixed to the esophagus and the other half is fixed to the diaphragm.
  6. Re-approximation of the diaphragmatic crura is performed posterior to the esophagus using interrupted 0 non-absorbable sutures. A calibration tube is used to judge the approximation limit.
  7. If there is no space for mesh fixation on the diaphragm, the left hepatic triangular ligament will be released.
  8. Toupét fundoplication fashioned by positioning of the fundus posterior to the esophagus. Three Interrupted 2-0 sutures are then used to anchor the stomach to the lower esophagus antero-laterally. Then, the left gastric segment is sutured to the esophagus antero-laterally, leaving a gap of 1.5 to 2 cm from the right gastric segment, completing a 270° wrap.
  9. The wrap is then anchored to the hiatus using interrupted 2-0 non-absorbable sutures.

Typically, four sutures are required to anchor the wrap to both the right and left crura as well as the anterior aspect of the diaphragmatic hiatus. The routine postoperative Care is achieved The Primary Outcome is the recurrence rate of hiatal hernia, as assessed by Endoscopy and imaging studies (e.g., barium meal in Trendelenburg position or endoscopy) at 1-2 years follow-up. Secondary Outcomes are the complication rates (e.g., dysphagia, mesh erosion, infection), Operative time, patient satisfaction and quality of life, hospital stay, readmission rate, Reoperation rate, Symptom improvement (e.g., reflux, chest pain), and coast Postoperative management Every day, vital signs such as heart rate, blood pressure, oxygen saturation, and intravenous fluid levels will be documented. Clear oral fluid will be initiated six hours after surgery. In the absence of any formal complaints, patients will be allowed to be discharged from the hospital. Follow up There are scheduled follow-up appointments at1,3,6,12, and 24 months postoperatively. The follow-up consisted of a clinical evaluation including presence of symptoms of GERD (heartburn, regurgitation, epigastric discomfort) or nonspecific symptoms such as dysphagia or vomiting), upper GIT endoscopy, radiographic barium meal in trendlenberge position and abdominal CT for selected patient. Statistical analysis For categorical variables, we utilized percentages and numbers as descriptive statistics, whereas for continuous variables, we used mean and standard deviations. The statistical analyses were conducted using SPSS 26 (SPSS Inc., Chicago, IL, USA).

Being tested
Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique), Classic approach
Keywords
hiatus hernia, Gastroesophageal reflux disease
Medical subject headings
Hernia, Hiatal, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique)Procedure or surgery

    Alinasser's technique of laparoscopic hiatal hernia repair (LHHR) is carried out, follow same steps of classical approach except before closing the crura A non-absorbable mesh (≈2.0 x 10.0 cm) is sutured to the esophagus( lower mediastinal esophagus) , just above the hiatus by four 2-0 prolene stitches. The continuity of the mesh is then fixed just below the hiatus anteriorly on the abdominal face of diaphragm by four 2-0 prolene stitches. About half of the mesh is fixed to the esophagus and the other half is fixed to the diaphragm. If there is no space for mesh fixation on the diaphragm, the left hepatic triangular ligament will be released.

  • Classic approachProcedure or surgery

    Classic approach of laparoscopic hiatal hernia repair (LHHR) is performed under general anesthesia with the patient in the French position and pneumoperitoneum established at 15 mmHg CO₂. Port placement follows a standardized foregut approach, with a camera port in the epigastrium and additional working ports placed under direct vision. After retracting the left lobe of the liver, the diaphragmatic hiatus is exposed. The stomach and hernia sac are reduced by dividing short gastric vessels and mobilizing the gastric fundus to free the left crus. Circumferential dissection of the hernia sac continues cranially to gain at least 3-5 cm of intraabdominal esophageal length.The diaphragmatic crura are approximated posterior to the esophagus, aided by a calibration tube. If necessary. A posterior 270° Toupét fundoplication is then constructed with interrupted stitches, anchoring the wrap to the esophagus and crura.

Study groups in NCT07251010
Study groupRoleWhat they receive
Classic approach (Standard of Care)ExperimentalStandard Surgical Procedure Hiatal hernia repair no Mesh
Receives: Procedure: Classic approach
Hiatal Hernia Repair and Phrenoesophageal Ligament Reconstruction with Mesh (Alinasser technique)ExperimentalA New Approach
Receives: Procedure: Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The recurrence rate of hiatal hernia by imaging and endoscopy

    Imaging-based diagnosis: Most studies utilize radiological evaluation, such as esophagram (fluoroscopic imaging), CT scans, or barium swallow tests, to detect the anatomical recurrence of the hernia. Definitions of recurrence include any evidence of the stomach above the diaphragm or more than 2 cm of herniation above the diaphragm.

    Endoscopic assessment: Esophagogastroduodenoscopy (EGD) is also used to identify recurrences.

    Recurrence rate= (number of recurrent patient/total arm patient) x100

    Measured: 12 Months Post- surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start1 Mar 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251010
Sponsor's protocol ID
AHC-RCT-4-2025
Other IDs
AHC-RCT-4-2025
Status last verified
Feb 2026
First submitted
24 Sep 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Asti E, Lovece A, Bonavina L, Milito P, Sironi A, Bonitta G, Siboni S. Laparoscopic management of large hiatus hernia: five-year cohort study and comparison of mesh-augmented versus standard crura repair. Surg Endosc. 2016 Dec;30(12):5404-5409. doi: 10.1007/s00464-016-4897-7. Epub 2016 Apr 29.

    PubMed 27129562
  • Memon MA, Memon B, Yunus RM, Khan S. Suture Cruroplasty Versus Prosthetic Hiatal Herniorrhaphy for Large Hiatal Hernia: A Meta-analysis and Systematic Review of Randomized Controlled Trials. Ann Surg. 2016 Feb;263(2):258-66. doi: 10.1097/SLA.0000000000001267.

    PubMed 26445468
  • Zehetner J, Demeester SR, Ayazi S, Kilday P, Augustin F, Hagen JA, Lipham JC, Sohn HJ, Demeester TR. Laparoscopic versus open repair of paraesophageal hernia: the second decade. J Am Coll Surg. 2011 May;212(5):813-20. doi: 10.1016/j.jamcollsurg.2011.01.060. Epub 2011 Mar 23.

    PubMed 21435915
  • Morino M, Giaccone C, Pellegrino L, Rebecchi F. Laparoscopic management of giant hiatal hernia: factors influencing long-term outcome. Surg Endosc. 2006 Jul;20(7):1011-6. doi: 10.1007/s00464-005-0550-6. Epub 2006 Jun 8.

    PubMed 16763927

Questions about this trial

What is this clinical trial studying?

A study testing Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) and Classic approach in people with Hiatus Hernia and Gastreoesophageal Reflux Disease, run by Clinical Trial Aseer at 2 sites in Saudi Arabia.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. 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?

Contact Ali Nasser AlQahtani (+966558015206, dr.alinasser@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The recurrence rate of hiatal hernia by imaging and endoscopy (time frame: 12 Months Post- surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07251010, which also lists 4 linked publications.

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 23 Oct 2026.

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