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

January 17, 2024 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bayonne, France, 64100
        • Not yet recruiting
        • CH de la Côte Basque
        • Contact:
        • Principal Investigator:
          • Laura Etchechoury, MD
      • Besançon, France, 25000
        • Not yet recruiting
        • Hôpital Jean Minjoz, CHRU de Besançon
        • Contact:
        • Principal Investigator:
          • Pierre Mathieu, MD
      • Brest, France, 29000
        • Not yet recruiting
        • Hôpital Cavale blanche, CHRU de Brest
        • Contact:
        • Principal Investigator:
          • Jérémie Théréaux, MD
      • Caen, France, 14000
        • Not yet recruiting
        • Hôpital Côte de nacre, CHU Caen Normandie
        • Principal Investigator:
          • Gil Lebreton, MD
        • Contact:
      • Clermont-Ferrand, France, 63000
      • Colombes, France, 92700
        • Not yet recruiting
        • Hôpital Louis-Mourier, AP-HP
        • Contact:
        • Principal Investigator:
          • David Moszkowicz, MD
      • La Tronche, France, 38700
        • Not yet recruiting
        • Hôpital Nord, CHU de Grenoble
        • Contact:
        • Principal Investigator:
          • Fabian Reche, MD, PhD
      • Lille, France, 59000
        • Not yet recruiting
        • Hôpital Claude Huriez, CHRU de Lille
        • Contact:
        • Principal Investigator:
          • Guillaume Piessen, MD, PhD
      • Lille, France, 5900
        • Not yet recruiting
        • Polyclinique du bois, Hôpital privé Le Bois
        • Contact:
        • Principal Investigator:
          • Nicolas Briez, MD
      • Limoges, France, 87000
        • Not yet recruiting
        • Hôpital Dupuytren 1, CHU de Limoges
        • Contact:
        • Principal Investigator:
          • Muriel Mathonnet, MD, PhD
      • Lyon, France, 69000
        • Not yet recruiting
        • Hôpital de la Croix-Rousse, HCL
        • Contact:
        • Principal Investigator:
          • Salim Mezoughi, MD
      • Montpellier, France, 34000
        • Not yet recruiting
        • Hôpital Saint Eloi, CHU de Montpellier
        • Contact:
        • Principal Investigator:
          • Jean-Michel Fabre, MD, PhD
      • Nantes, France, 44000
        • Not yet recruiting
        • Hôpital Hôtel Dieu, CHU de Nantes
        • Contact:
        • Principal Investigator:
          • Claire Blanchard, MD
      • Nice, France, 06000
        • Not yet recruiting
        • Hôpital Archet, CHU de Nice
        • Contact:
        • Principal Investigator:
          • Antonio Ianelli, MD, PhD
      • Paris, France, 75014
        • Not yet recruiting
        • Institut Mutualiste Montsouris
        • Contact:
        • Principal Investigator:
          • Stéphane Bonnet, MD, PhD
      • Paris, France, 75010
        • Not yet recruiting
        • Hôpital Saint-Louis, AP-HP
        • Principal Investigator:
          • Hélène Corte, MD
        • Contact:
      • Paris, France, 75012
        • Not yet recruiting
        • Hôpital Saint-Antoine, AP-HP
        • Contact:
        • Principal Investigator:
          • Emmanuel Attal, MD
      • Paris, France, 75013
        • Not yet recruiting
        • DMU SAPERE, CHU Pitié-Salpêtrière APHP
        • Contact:
        • Principal Investigator:
          • Laurent Genser, MD
      • Paris, France, 75018
        • Not yet recruiting
        • Hôpital Bichat, AP-HP
        • Contact:
        • Principal Investigator:
          • Simon Msika, MD, PhD
      • Pessac, France, 33600
        • Recruiting
        • Hôpital du Haut Lévêque
        • Contact:
        • Principal Investigator:
          • Caroline Gronnier, MD, PhD
      • Poitiers, France, 86000
        • Not yet recruiting
        • Hôpital Jean-Bernard, CHU de Poitiers
        • Contact:
        • Principal Investigator:
          • Jean-Pierre Faure, MD, PhD
      • Pontoise, France, 95000
        • Recruiting
        • CH René-Dubos
        • Contact:
        • Principal Investigator:
          • Nelson Trelles, MD
      • Rennes, France, 35000
        • Not yet recruiting
        • CHU de Rennes, Site PONTCHAILLOU
        • Contact:
        • Principal Investigator:
          • Damien Bergeat, MD
      • Rouen, France, 76000
        • Not yet recruiting
        • Hôpital Charles Nicolle, CHU de Rouen
        • Contact:
        • Principal Investigator:
          • Emmanuel Huet, MD
      • Saint Paul, France, 97415
        • Not yet recruiting
        • Hôpital Felix-Guyon, CHU de la Réunion
        • Contact:
        • Principal Investigator:
          • Radwan Kassir, MD
      • Toulouse, France, 31000
        • Not yet recruiting
        • Hôpital Rangueil, CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Nicolas Carrere, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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
Sham Comparator: No biosynthetic absorbable mesh
Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh
Procedure: Laparoscopic hiatal hernia repair
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Large Hiatal Hernia recurrence
Time Frame: Month 24
Radiologic recurrence will be identified at 24 months by an experienced radiologist blinded to the result of randomization and defined as the presence of any abdominal content located above the level of the diaphragm on CT-scan.
Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Quality of life (QoL) by GIQLI,
Time Frame: Day 0
GIQLI questionnaire includes 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments. The score is between 0 and 144. The higher is the score, better is the quality of life.
Day 0
Evaluation of Quality of life (QoL) by GIQLI,
Time Frame: Month 1
GIQLI questionnaire includes 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments. The score is between 0 and 144. The higher is the score, better is the quality of life.
Month 1
Evaluation of Quality of life (QoL) by GIQLI,
Time Frame: Month 6
GIQLI questionnaire includes 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments. The score is between 0 and 144. The higher is the score, better is the quality of life.
Month 6
Evaluation of Quality of life (QoL) by GIQLI,
Time Frame: Month 12
GIQLI questionnaire includes 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments. The score is between 0 and 144. The higher is the score, better is the quality of life.
Month 12
Evaluation of Quality of life (QoL) by GIQLI,
Time Frame: Month 24
GIQLI questionnaire includes 36 items relating to symptoms, physical status, emotions, social problems, and the effect of medical treatments. The score is between 0 and 144. The higher is the score, better is the quality of life.
Month 24
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time Frame: Day 0
SF36 questionnaire consists of 36 items, including eight health-related scales: general physical condition, physical health role limitations, body pain, general health perception, vitality, social functioning, health role limitations psychic. The score is between 36 and 180. The higher is the score, better is the quality of life.
Day 0
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time Frame: Month 1
SF36 questionnaire consists of 36 items, including eight health-related scales: general physical condition, physical health role limitations, body pain, general health perception, vitality, social functioning, health role limitations psychic. The score is between 36 and 180. The higher is the score, better is the quality of life.
Month 1
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time Frame: Month 6
SF36 questionnaire consists of 36 items, including eight health-related scales: general physical condition, physical health role limitations, body pain, general health perception, vitality, social functioning, health role limitations psychic. The score is between 36 and 180. The higher is the score, better is the quality of life.
Month 6
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time Frame: Month 12
SF36 questionnaire consists of 36 items, including eight health-related scales: general physical condition, physical health role limitations, body pain, general health perception, vitality, social functioning, health role limitations psychic. The score is between 36 and 180. The higher is the score, better is the quality of life.
Month 12
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time Frame: Month 24
SF36 questionnaire consists of 36 items, including eight health-related scales: general physical condition, physical health role limitations, body pain, general health perception, vitality, social functioning, health role limitations psychic. The score is between 36 and 180. The higher is the score, better is the quality of life.
Month 24
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time Frame: Day 0
EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score is between 5 and 25. The lower is the score, better is the quality of life.
Day 0
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time Frame: Month 1
EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score is between 5 and 25. The lower is the score, better is the quality of life.
Month 1
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time Frame: Month 6
EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score is between 5 and 25. The lower is the score, better is the quality of life.
Month 6
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time Frame: Month 12
EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score is between 5 and 25. The lower is the score, better is the quality of life.
Month 12
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time Frame: Month 24
EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score is between 5 and 25. The lower is the score, better is the quality of life.
Month 24
Evaluation of Quality of life (QoL) by EQ-VAS
Time Frame: Day 0
EQ-VAS questionnaire asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" (score 0) to "best possible" health (score 100).
Day 0
Evaluation of Quality of life (QoL) by EQ-VAS
Time Frame: Month 1
EQ-VAS questionnaire asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" (score 0) to "best possible" health (score 100).
Month 1
Evaluation of Quality of life (QoL) by EQ-VAS
Time Frame: Month 6
EQ-VAS questionnaire asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" (score 0) to "best possible" health (score 100).
Month 6
Evaluation of Quality of life (QoL) by EQ-VAS
Time Frame: Month 12
EQ-VAS questionnaire asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" (score 0) to "best possible" health (score 100).
Month 12
Evaluation of Quality of life (QoL) by EQ-VAS
Time Frame: Month 24
EQ-VAS questionnaire asks patients to indicate their overall health on a vertical visual analogue scale, ranging from "worst possible" (score 0) to "best possible" health (score 100).
Month 24
measurement of fever
Time Frame: Month 1
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Month 1
measurement of fever
Time Frame: Month 6
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Month 6
measurement of fever
Time Frame: Month 12
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Month 12
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Time Frame: Month 24
measuring fever with a thermometer
Month 24
measurement of weight
Time Frame: Day 0
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Day 0
measurement of weight
Time Frame: Month 1
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Month 1
measurement of weight
Time Frame: Month 6
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Month 6
measurement of weight
Time Frame: Month 12
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Month 12
measurement of weight
Time Frame: Month 24
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Month 24
measurement of blood pressure
Time Frame: Day 0
Systolic and diastolic blood pressure are measured in millimeter of mercury (mm Hg). Systolic blood pressure is between 70 and 220 mm Hg. Diastolic blood pressure is between 20 and 160 mm Hg.
Day 0
measurement of blood pressure
Time Frame: Month 1
Systolic and diastolic blood pressure are measured in millimeter of mercury (mm Hg). Systolic blood pressure is between 70 and 220 mm Hg. Diastolic blood pressure is between 20 and 160 mm Hg.
Month 1
measurement of blood pressure
Time Frame: Month 6
Systolic and diastolic blood pressure are measured in millimeter of mercury (mm Hg). Systolic blood pressure is between 70 and 220 mm Hg. Diastolic blood pressure is between 20 and 160 mm Hg.
Month 6
measurement of blood pressure
Time Frame: Month 12
Systolic and diastolic blood pressure are measured in millimeter of mercury (mm Hg). Systolic blood pressure is between 70 and 220 mm Hg. Diastolic blood pressure is between 20 and 160 mm Hg.
Month 12
measurement of blood pressure
Time Frame: Month 24
Systolic and diastolic blood pressure are measured in millimeter of mercury (mm Hg). Systolic blood pressure is between 70 and 220 mm Hg. Diastolic blood pressure is between 20 and 160 mm Hg.
Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Caroline Gronnier, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 18, 2028

Study Completion (Estimated)

January 18, 2028

Study Registration Dates

First Submitted

December 30, 2022

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2021/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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