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

University Hospital of Bordeaux

Status: Enrolling

Conditions: Large Hiatal Hernia

Treatments: Procedure: Laparoscopic hiatal hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05867225

CHUBX 2021/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Biosynthetic absorbable mesh

Experimental group

Description:

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

Treatment:

Procedure: Laparoscopic hiatal hernia repair

No biosynthetic absorbable mesh

Sham Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic hiatal hernia repair