Phrenoesophageal Ligament Reconstruction With Mesh

NCT07251010 | Not Yet Recruiting DMC

• 1 other identifier: AHC-RCT-4-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hiatus Hernia; Gastreoesophageal Reflux Disease

Keywords

hiatus hernia; Gastroesophageal reflux disease

Outcome Measures

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

  12 Months Post- surgery

Study Arms (2)

Classic approach (Standard of Care)

EXPERIMENTAL

Standard Surgical Procedure Hiatal hernia repair no Mesh

Procedure: Classic approach

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

EXPERIMENTAL

A New Approach

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

Interventions

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

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.

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

Classic approach PROCEDURE

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.

Classic approach (Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Trial Aseer: lead

Study Sites (1)

Asser Health Cluster

Abhā, 'Asir Region, 62521, Saudi Arabia

Location

Related Publications (4)

• 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.

  PMID: 27129562 BACKGROUND

• 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.

  PMID: 26445468 BACKGROUND

• 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.

  PMID: 21435915 BACKGROUND

• 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.

  PMID: 16763927 BACKGROUND

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Ali Nasser AlQahtani

CONTACT

+966558015206; dr.alinasser@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 26, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

SA (1)