Hiatal HerniaNCT04591860
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
A study testing Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet in people with Hiatal Hernia, run by Paracelsus Medical University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
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.
- Conditions
- Hiatal Hernia
- Being tested
- Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
- Keywords
- hiatal hernia, pledgets, mesh, hernia recurrence
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to ToupetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sutures only | Active comparator | Patients with a large hiatal hernia undergo the cruroplasty with sutures only.
A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. Receives: Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet |
| Absorbable Mesh | Active comparator | Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation.
A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. Receives: Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet |
| Pledgeted sutures | Active comparator | Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures.
A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. Receives: Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hiatal hernia recurrence rate
Hiatal hernia recurrence rate documented by gastroscopy
Measured: 6 months, 1 year, 3 years and 5 years after surgery
Secondary outcomes (7)
Quality of Life evaluated by questionnaire
Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
Measured: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Symptoms related to Gastroesophageal Reflux Disease (GERD)
Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.
Measured: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
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
Measured: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Postoperative complications
Short - term and long - term complications after treatment
Measured: 6 months, 1 year, 3 years and 5 years after surgery
Length of hospital stay
Length of hospital stay and mortality rates
Measured: up to 90 days
Predictive parameters for treatment response or failure I
Weight (in kilograms)
Measured: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Predictive parameters for treatment response or failure II
Height (in meters)
Measured: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 May 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hiatal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck, Medical University of Vienna, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital
- Responsible party
- Principal investigator, Michael Weitzendorfer, MD, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591860
- Sponsor's protocol ID
- Phasix™ST - Austria
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33567462
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
- ClinicalTrials.gov ID
- NCT04591860
- Acronym / sponsor ID
- Phasix™ST - Austria
- Conditions
- Hiatal Hernia
- Keywords
- hiatal hernia, pledgets, mesh, hernia recurrence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Collaborators
- Medical University Innsbruck, Medical University of Vienna, Krankenhaus Barmherzige Schwestern Linz, Elisabethinen Hospital
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sutures only | Active comparator | Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to ToupetPatients with a large hiatal hernia undergo the cruroplasty with sutures only. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. |
| Absorbable Mesh | Active comparator | Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to ToupetPatients with a large hiatal hernia undergo the cruroplasty with mesh implantation. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. |
| Pledgeted sutures | Active comparator | Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to ToupetPatients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures. A large hiatal hernia is defined as > 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to ToupetPatients 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. | Device | Absorbable Mesh, Pledgeted sutures, Sutures only |
Primary outcome
Hiatal hernia recurrence rate
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Hiatal hernia recurrence rate documented by gastroscopy
7 secondary outcomes
Quality of Life evaluated by questionnaire
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Symptoms related to Gastroesophageal Reflux Disease (GERD)
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Postoperative complications
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Length of hospital stay
Time frame: up to 90 days
Predictive parameters for treatment response or failure I
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Predictive parameters for treatment response or failure II
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 33567462Koch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet in people with Hiatal Hernia, run by Paracelsus Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Weitzendorfer, MD, PhD (+435725551078, m.weitzendorfer@salk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hiatal hernia recurrence rate (time frame: 6 months, 1 year, 3 years and 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04591860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.