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NCT05867225 | Recruiting | Large Hiatal Hernia


Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Sponsor:

University Hospital, Bordeaux

Brief Summary:

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. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.

Condition or disease

Large Hiatal Hernia

Intervention/treatment

Laparoscopic hiatal hernia repair

Phase

Not Applicable

Detailed Description:

The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. Aging of the population and improvement of perioperative management may suggest that the number of these interventions will increase in the next few years. However, recurrence is common and has been described in up to 30% of patients who have undergone laparoscopic repair after a median follow up of 24 months. The use of mesh reinforcement has been suggested to help preventing recurrence after LHH repair with non-absorbable and absorbable mesh. 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. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH. The secondary objectives are : To compare the improvement of specific symptoms between two arms; To compare the Quality of life; To compare the complication rate and thecomplication severity according to the Clavien-Dindo classification; To assess the cost-effectiveness of standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair as compared to standardized herniorrhaphy with no mesh, in symptomatic LHH, at 2 years, from the French Healthcare system point of view. The expected benefits are : for the patient the diminution of LHH recurrence rate, quality of life improvement for Public health: Reducing the rate of reoperation for LHH; Reduction of healthcare costs due to a decrease in proton pump consumption and surgical re-interventions; The use of a synthetic bioprosthesis in laparoscopic surgery could be largely recommended and reimbursed either through the tariff related to the hospital stay (DRG tariff) or in additionto this tariff; Long term follow-up up to 5 years, could be obtained thanks to the use of French health insurance databases.

Study Type : Interventional
Estimated Enrollment : 256 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia: a Multicenter, Randomized, Parallel-group, Evaluator Blinded, Phase III Clinical Trial
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : January 18, 2028
Estimated Study Completion Date : January 18, 2028
Arm Intervention/treatment

Experimental: Biosynthetic absorbable mesh

Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh

Procedure: Laparoscopic hiatal hernia repair

Sham Comparator: No biosynthetic absorbable mesh

Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh

Procedure: Laparoscopic hiatal hernia repair

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion 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 with contrast injection with axial reconstruction.
  • 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).
Exclusion Criteria
  • 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.

Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia

Location Details


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Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

France,

CH de la Côte Basque

Bayonne, France, 64100

Not yet recruiting

France,

Hôpital Jean Minjoz, CHRU de Besançon

Besançon, France, 25000

Not yet recruiting

France,

Hôpital Cavale blanche, CHRU de Brest

Brest, France, 29000

Not yet recruiting

France,

Hôpital Côte de nacre, CHU Caen Normandie

Caen, France, 14000

Not yet recruiting

France,

Hôpital Estang

Clermont-Ferrand, France, 63000

Not yet recruiting

France,

Hôpital Louis-Mourier, AP-HP

Colombes, France, 92700

Not yet recruiting

France,

Hôpital Nord, CHU de Grenoble

La Tronche, France, 38700

Not yet recruiting

France,

Hôpital Claude Huriez, CHRU de Lille

Lille, France, 59000

Not yet recruiting

France,

Polyclinique du bois, Hôpital privé Le Bois

Lille, France, 5900

Not yet recruiting

France,

Hôpital Dupuytren 1, CHU de Limoges

Limoges, France, 87000

Not yet recruiting

France,

Hôpital de la Croix-Rousse, HCL

Lyon, France, 69000

Not yet recruiting

France,

Hôpital Saint Eloi, CHU de Montpellier

Montpellier, France, 34000

Not yet recruiting

France,

Hôpital Hôtel Dieu, CHU de Nantes

Nantes, France, 44000

Not yet recruiting

France,

Hôpital Archet, CHU de Nice

Nice, France, 06000

Not yet recruiting

France,

Hôpital Saint-Louis, AP-HP

Paris, France, 75010

Not yet recruiting

France,

Hôpital Saint-Antoine, AP-HP

Paris, France, 75012

Not yet recruiting

France,

DMU SAPERE, CHU Pitié-Salpêtrière APHP

Paris, France, 75013

Not yet recruiting

France,

Institut Mutualiste Montsouris

Paris, France, 75014

Not yet recruiting

France,

Hôpital Bichat, AP-HP

Paris, France, 75018

Recruiting

France,

Hôpital du Haut Lévêque

Pessac, France, 33600

Not yet recruiting

France,

Hôpital Jean-Bernard, CHU de Poitiers

Poitiers, France, 86000

Recruiting

France,

CH René-Dubos

Pontoise, France, 95000

Not yet recruiting

France,

CHU de Rennes, Site PONTCHAILLOU

Rennes, France, 35000

Not yet recruiting

France,

Hôpital Charles Nicolle, CHU de Rouen

Rouen, France, 76000

Not yet recruiting

France,

Hôpital Felix-Guyon, CHU de la Réunion

Saint Paul, France, 97415

Not yet recruiting

France,

Hôpital Rangueil, CHU de Toulouse

Toulouse, France, 31000

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