An interventional study of Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet in Hiatal Hernia, sponsored by Paracelsus Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Paracelsus Medical University · Not applicable, Interventional, and Treatment
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's planned enrollment of 165 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Paracelsus Medical University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.
Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet
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.
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.
Hiatal hernia recurrence rate
Hiatal hernia recurrence rate documented by gastroscopy
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Quality of Life evaluated by questionnaire
Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 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.
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)
Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
Postoperative complications
Short - term and long - term complications after treatment
Time frame: 6 months, 1 year, 3 years and 5 years after surgery
Length of hospital stay
Length of hospital stay and mortality rates
Time frame: up to 90 days
Predictive parameters for treatment response or failure I
Weight (in kilograms)
Time frame: 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)
Time frame: Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Paracelsus Medical University