Clinical trial NCT05867225: Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Large Hiatal Hernia
Keywords: Large Hiatal Hernia
Recurrence
Surgery
Biosynthetic absorbable mesh
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Large Hiatal Hernia recurrence
timeFrame: Month 24
Secondary outcomes:
measure: Evaluation of Quality of life (QoL) by GIQLI,
timeFrame: Day 0
measure: Evaluation of Quality of life (QoL) by GIQLI,
timeFrame: Month 1
measure: Evaluation of Quality of life (QoL) by GIQLI,
timeFrame: Month 6
measure: Evaluation of Quality of life (QoL) by GIQLI,
timeFrame: Month 12
measure: Evaluation of Quality of life (QoL) by GIQLI,
timeFrame: Month 24
measure: Evaluation of Quality of life (QoL) by SF36 questionnaire
timeFrame: Day 0
measure: Evaluation of Quality of life (QoL) by SF36 questionnaire
timeFrame: Month 1
measure: Evaluation of Quality of life (QoL) by SF36 questionnaire
timeFrame: Month 6
measure: Evaluation of Quality of life (QoL) by SF36 questionnaire
timeFrame: Month 12
measure: Evaluation of Quality of life (QoL) by SF36 questionnaire
timeFrame: Month 24
measure: Evaluation of Quality of life (QoL) by EQ-5D-5L
timeFrame: Day 0
measure: Evaluation of Quality of life (QoL) by EQ-5D-5L
timeFrame: Month 1
measure: Evaluation of Quality of life (QoL) by EQ-5D-5L
timeFrame: Month 6
measure: Evaluation of Quality of life (QoL) by EQ-5D-5L
timeFrame: Month 12
measure: Evaluation of Quality of life (QoL) by EQ-5D-5L
timeFrame: Month 24
measure: Evaluation of Quality of life (QoL) by EQ-VAS
timeFrame: Day 0
measure: Evaluation of Quality of life (QoL) by EQ-VAS
timeFrame: Month 1
measure: Evaluation of Quality of life (QoL) by EQ-VAS
timeFrame: Month 6
measure: Evaluation of Quality of life (QoL) by EQ-VAS
timeFrame: Month 12
measure: Evaluation of Quality of life (QoL) by EQ-VAS
timeFrame: Month 24
measure: measurement of fever
timeFrame: Month 1
measure: measurement of fever
timeFrame: Month 6
measure: measurement of fever
timeFrame: Month 12
measure: measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
timeFrame: Month 24
measure: measurement of weight
timeFrame: Day 0
measure: measurement of weight
timeFrame: Month 1
measure: measurement of weight
timeFrame: Month 6
measure: measurement of weight
timeFrame: Month 12
measure: measurement of weight
timeFrame: Month 24
measure: measurement of blood pressure
timeFrame: Day 0
measure: measurement of blood pressure
timeFrame: Month 1
measure: measurement of blood pressure
timeFrame: Month 6
measure: measurement of blood pressure
timeFrame: Month 12
measure: measurement of blood pressure
timeFrame: Month 24
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besançon
country: France
facility: Hôpital Jean Minjoz, CHRU de Besançon
city: Brest
country: France
facility: Hôpital Cavale blanche, CHRU de Brest
city: Caen
country: France
facility: Hôpital Côte de nacre, CHU Caen Normandie
city: Clermont-Ferrand
country: France
facility: Hôpital Estang
city: Colombes
country: France
facility: Hôpital Louis-Mourier, AP-HP
city: La Tronche
country: France
facility: Hôpital Nord, CHU de Grenoble
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU de Lille
city: Lille
country: France
facility: Polyclinique du bois, Hôpital privé Le Bois
city: Limoges
country: France
facility: Hôpital Dupuytren 1, CHU de Limoges
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse, HCL
city: Montpellier
country: France
facility: Hôpital Saint Eloi, CHU de Montpellier
city: Nantes
country: France
facility: Hôpital Hôtel Dieu, CHU de Nantes
city: Nice
country: France
facility: Hôpital Archet, CHU de Nice
city: Paris
country: France
facility: Hôpital Saint-Louis, AP-HP
city: Paris
country: France
facility: Hôpital Saint-Antoine, AP-HP
city: Paris
country: France
facility: DMU SAPERE, CHU Pitié-Salpêtrière APHP
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Bichat, AP-HP
city: Pessac
country: France
facility: Hôpital du Haut Lévêque
city: Poitiers
country: France
facility: Hôpital Jean-Bernard, CHU de Poitiers
city: Pontoise
country: France
facility: CH René-Dubos
city: Rennes
country: France
facility: CHU de Rennes, Site PONTCHAILLOU
city: Rouen
country: France
facility: Hôpital Charles Nicolle, CHU de Rouen
city: Saint Paul
country: France
facility: Hôpital Felix-Guyon, CHU de la Réunion
city: Toulouse
country: France
facility: Hôpital Rangueil, CHU de Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Caroline Gronnier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: