Clinical trial NCT04591860: A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
Official title: A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiatal Hernia
Keywords: hiatal hernia
pledgets
mesh
hernia recurrence
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Medical University of Vienna
name: Krankenhaus Barmherzige Schwestern Linz
name: Elisabethinen Hospital
First posted: 2020-10-19
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as \> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up 6 months, 1 year, 3 years and 5 years after the operation using standardized questionnaires and gastroscopy.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hiatal hernia recurrence rate
timeFrame: 6 months, 1 year, 3 years and 5 years after surgery
Secondary outcomes:
measure: Quality of Life evaluated by questionnaire
timeFrame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
measure: Symptoms related to Gastroesophageal Reflux Disease (GERD)
timeFrame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
measure: Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)
timeFrame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
measure: Postoperative complications
timeFrame: 6 months, 1 year, 3 years and 5 years after surgery
measure: Length of hospital stay
timeFrame: up to 90 days
measure: Predictive parameters for treatment response or failure I
timeFrame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
measure: Predictive parameters for treatment response or failure II
timeFrame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Koch O, von Rahden BHA, Wykypiel H, Schoppmann SF, Fugger R, Rosanelli G, Emmanuel K, Weitzendorfer M. [Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh]. Zentralbl Chir. 2021 Apr;146(2):204-209. doi: 10.1055/a-1369-9694. Epub 2021 Feb 10. German.