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RecruitingNCT07251010Updated Oct 23, 2026

Phrenoesophageal Ligament Reconstruction With Mesh

An interventional study of Phrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique) and Classic approach in Hiatus Hernia and Gastreoesophageal Reflux Disease, sponsored by Clinical Trial Aseer. Recruiting at 2 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Clinical Trial Aseer · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Oct 23, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Hiatus Hernia
  • Gastreoesophageal Reflux Disease

Keywords

  • hiatus hernia
  • Gastroesophageal reflux disease
03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

This is the only study on the registry with Clinical Trial Aseer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Eligibility criteria have been reformatted as follows:

    #Inclusion Criteria:

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

    #Exclusion Criteria:

  • Children (\<18 years)
  • Recurrent hiatus hernia
  • Post-bariatric surgery
  • Pregnancy
  • Crohn's disease
  • Emergency surgery cases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Classic approach (Standard of Care)

    Standard Surgical Procedure Hiatal hernia repair no Mesh

    Procedure: Classic approach

  • Experimental
    Hiatal Hernia Repair and Phrenoesophageal Ligament Reconstruction with Mesh (Alinasser technique)

    A New Approach

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

Interventions

  • ProcedurePhrenoesophageal Ligament Reconstruction with Mesh: A New Approach to Hiatal Hernia Repair (Alinasser's Technique)

    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.

  • ProcedureClassic approach

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 12 Months Post- surgery

07

Study locations

1 of 2 sites recruiting
  • Asser Health Cluster
    Abhā, 'Asir Region 62521, Saudi Arabia
    Not yet recruiting
  • Aseer central hospital
    Abhā, 'Asir Region, Saudi Arabia
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Nov 2027, 20 months after the start.

Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 20 months is below that.

Start moved once since we started tracking on Sep 25, 2026: Dec 2025 → Mar 2026, on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2025
First posted
Nov 26, 2025
StartActual
Mar 1, 2026was Dec 2025
Primary completionEst.
Nov 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
1 site added. Asser Health Cluster is now Not yet recruiting
Show site
  • Aseer central hospital · Abhā, Saudi Arabia
Oct 23, 2026
Start date
Dec 20, 2025→Mar 1, 2026 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    1 site added. Asser Health Cluster is now Not yet recruiting
    Show site
    • Aseer central hospital · Abhā, Saudi Arabia
    Start date Dec 20, 2025→Mar 1, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07251010
Lead sponsor
Clinical Trial Aseer
Responsible party
Sponsor
First posted
Nov 26, 2025
Start date
Mar 1, 2026
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Ali Nasser AlQahtani
Contact
dr.alinasser@windowslive.com
+966558015206

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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