Phrenoesophageal Ligament Reconstruction With Mesh

NCT ID: NCT07251010

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2027-12-31

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

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).

Conditions

Hiatus Hernia; Gastreoesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Classic approach (Standard of Care)

Standard Surgical Procedure Hiatal hernia repair no Mesh

Group Type: EXPERIMENTAL

Classic approach

Intervention Type: 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.

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

A New Approach

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Phrenoesophageal 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.

Intervention Type: PROCEDURE

Classic 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Aseer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asser Health Cluster

Abhā, 'Asir Region, Saudi Arabia

Countries

Saudi Arabia

Central Contacts

Ali Nasser AlQahtani

Role: CONTACT

dr.alinasser@windowslive.com

+966558015206

Facility Contacts

Ali Nasser Alqahtani

Role: primary

aalqahtani174@moh.gov.sa

+966558015206

References

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.

Reference Type: BACKGROUND

PMID: 27129562 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26445468 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21435915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16763927 (View on PubMed)

Other Identifiers

AHC-RCT-4-2025

Identifier Type: OTHER

Identifier Source: secondary_id

AHC-RCT-4-2025

Identifier Type: -

Identifier Source: org_study_id