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Compares treatment options for Large Hiatal Hernia
Official title Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
ClinicalTrials.gov ID: NCT05867225
What this study is testing
- What it's testing
- The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined as a hiatal hernia larger than 5 cm in axial length as diagnosed...
- Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain and/or dysphagia and/or anemia (if exclusion of other origin);
- Patient aged ≥ 18 years;
- Patient affiliated to a social security system or beneficiary of the same;
- Free written informed consent signed by the participant and the investigator (no later than the inclusion day and before performing any examination...
You likely can't join if
- Patient undergoing reoperation for recurrent LHH repair;
- Emergency presentation needing an operation in a delay \<6 hours;
- Asymptomatic hiatal hernia;
- American anesthesiologist score \>3;
- Recurrent hiatal hernia and previous surgical interventions involving gastroesophageal junction;
- Brachyesophagus defined as the impossibility to achieve an intraabdominal length of the esophagus of at least 3cm after reduction of hernia contents...
See the full eligibility criteria
- Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined as a hiatal hernia larger than 5 cm in axial length as diagnosed at barium series and/or CT-scan with contrast swallow and/or CT-scan...
- Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain and/or dysphagia and/or anemia (if exclusion of other origin);
- Patient aged ≥ 18 years;
- Patient affiliated to a social security system or beneficiary of the same;
- Free written informed consent signed by the participant and the investigator (no later than the inclusion day and before performing any examination required for the study).
- Patient undergoing reoperation for recurrent LHH repair;
- Emergency presentation needing an operation in a delay \<6 hours;
- Asymptomatic hiatal hernia;
- American anesthesiologist score \>3;
- Recurrent hiatal hernia and previous surgical interventions involving gastroesophageal junction;
- Brachyesophagus defined as the impossibility to achieve an intraabdominal length of the esophagus of at least 3cm after reduction of hernia contents and complete dissection and resection of the hernia sac;
- Previous major upper gastrointestinal surgery;
- Inability to perform primary closure of the crura;
- Pregnant or breast-feeding woman;
- Persons deprived of liberty or under guardianship or incapable of giving consent;
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Bayonne, France
- Besançon, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Colombes, France
- La Tronche, France
- Lille, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Poitiers, France
- Pontoise, France
- Rennes, France
- Rouen, France
- Saint-Paul, France
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayonne, France; Besançon, France; Brest, France; Caen, France; Clermont-Ferrand, France; Colombes, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.