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Onlay Synthetic Bioabsorbable...

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

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2028-01-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Large Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Biosynthetic absorbable mesh

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

Group Type EXPERIMENTAL

Laparoscopic hiatal hernia repair

Intervention Type PROCEDURE

laparoscopic hiatal hernia repair has replaced the traditional laparotomic or thoracotomic approach, and has resulted in a reduction of length of hospital stay and morbidity, and increased patients' acceptance

No biosynthetic absorbable mesh

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

Group Type SHAM_COMPARATOR

Laparoscopic hiatal hernia repair

Intervention Type PROCEDURE

Interventions

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Laparoscopic hiatal hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Gronnier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

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Caroline Gronnier, MD, PhD

Role: CONTACT

[email protected]

+ 33 5 57 65 60 05

Valérie Aurillac-Lavignolle

Role: CONTACT

[email protected]

+33 5 57 82 24 77

Facility Contacts

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Laura Etchechoury, MD

Role: primary

[email protected]

+335.59.44.35.02

Pierre Mathieu, MD

Role: primary

[email protected]

+333 81 66 83 22

Jérémie Théréaux, MD

Role: primary

[email protected]

+332 98 34 72 35

Gil Lebreton, MD

Role: primary

[email protected]

+332.31.06.32.21

CHUBX 2021/23

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair

Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Detailed Description

Conditions

Study Design

Study Groups

Biosynthetic absorbable mesh

Laparoscopic hiatal hernia repair

No biosynthetic absorbable mesh

Laparoscopic hiatal hernia repair

Interventions

Laparoscopic hiatal hernia repair

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

University Hospital, Bordeaux

Responsible Party

Principal Investigators

Caroline Gronnier, MD, PhD

Locations

CH de la Côte Basque

Hôpital Jean Minjoz, CHRU de Besançon

Hôpital Cavale blanche, CHRU de Brest

Hôpital Côte de nacre, CHU Caen Normandie

Hôpital Estang

Hôpital Louis-Mourier, AP-HP

Hôpital Nord, CHU de Grenoble

Hôpital Claude Huriez, CHRU de Lille

Polyclinique du bois, Hôpital privé Le Bois

Hôpital Dupuytren 1, CHU de Limoges

Hôpital de la Croix-Rousse, HCL

Hôpital Saint Eloi, CHU de Montpellier

Hôpital Hôtel Dieu, CHU de Nantes

Hôpital Archet, CHU de Nice

Hôpital Saint-Louis, AP-HP

Hôpital Saint-Antoine, AP-HP

DMU SAPERE, CHU Pitié-Salpêtrière APHP

Institut Mutualiste Montsouris

Hôpital Bichat, AP-HP

Hôpital du Haut Lévêque

Hôpital Jean-Bernard, CHU de Poitiers

CH René-Dubos

CHU de Rennes, Site PONTCHAILLOU

Hôpital Charles Nicolle, CHU de Rouen

Hôpital Felix-Guyon, CHU de la Réunion

Hôpital Rangueil, CHU de Toulouse

Countries

Central Contacts

Caroline Gronnier, MD, PhD

Valérie Aurillac-Lavignolle

Facility Contacts

Laura Etchechoury, MD

Pierre Mathieu, MD

Jérémie Théréaux, MD

Gil Lebreton, MD

Olivier Antomarchi, MD

David Moszkowicz, MD

Fabian Reche, MD, PhD

Guillaume Piessen, MD, PhD

Nicolas Briez, MD

Muriel Mathonnet, MD, PhD

Salim Mezoughi, MD

Jean-Michel Fabre, MD, PhD

Claire Blanchard, MD

Antonio Ianelli, MD, PhD

Hélène Corte, MD

Emmanuel Attal, MD

Laurent Genser, MD

Stéphane Bonnet, MD, PhD

Simon Msika, MD, PhD

Caroline Gronnier, MD, PhD