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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04591860
Other study ID # Phasix™ST - Austria
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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