A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

Hiatal Hernia Clinical Trial

Official title:

A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04591860
• Other study ID #: Phasix™ST - Austria
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: Paracelsus Medical University
• Contact: Michael Weitzendorfer, MD, PhD
• Phone: +435725551078
• Email: m.weitzendorfer[@]salk.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh). The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
• Written informed consent
• = 18 years of age
• Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or

more of the following criteria:

• > 5cm hiatal hernia
• 1/3 of the stomach in the thorax

Exclusion Criteria:

• Lack of patient consent for study participation
• Lack of consent to study due to linguistic or mental incomprehension
• Patients in poor general condition (lack of anesthesia ability)
• Pregnancy
• Prior surgery on the stomach or gastroesophageal junction
• Simultaneous surgery because of another illness

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Device:
• Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Paracelsus Medical University	Elisabethinen Hospital, Krankenhaus Barmherzige Schwestern Linz, Medical University Innsbruck, Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hiatal hernia recurrence rate	Hiatal hernia recurrence rate documented by gastroscopy	6 months, 1 year, 3 years and 5 years after surgery
Secondary	Quality of Life evaluated by questionnaire	Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Secondary	Symptoms related to Gastroesophageal Reflux Disease (GERD)	Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Secondary	Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)	Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Secondary	Postoperative complications	Short - term and long - term complications after treatment	6 months, 1 year, 3 years and 5 years after surgery
Secondary	Length of hospital stay	Length of hospital stay and mortality rates	up to 90 days
Secondary	Predictive parameters for treatment response or failure I	Weight (in kilograms)	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Secondary	Predictive parameters for treatment response or failure II	Height (in meters)	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery