Large Hiatal HerniaHIATUSNCT05867225
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
A study testing Laparoscopic hiatal hernia repair in people with Large Hiatal Hernia, run by University Hospital, Bordeaux at 26 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Hiatal Hernia
- What is being tested?
- Laparoscopic hiatal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 26 sitesFrance
- Study dates
- 15 Jan 2024to 18 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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 locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
France26 sites, 26 recruiting
- Not yet recruiting
CH de la Côte Basque
Bayonne, 64100
Laura Etchechoury, MD, +335.59.44.35.02, atunita64@hotmail.com
Laura Etchechoury, MD
- Not yet recruiting
Hôpital Jean Minjoz, CHRU de Besançon
Besançon, 25000
Pierre Mathieu, MD, +333 81 66 83 22, pmathieu@chu-besancon.fr
Pierre Mathieu, MD
- Not yet recruiting
Hôpital Cavale blanche, CHRU de Brest
Brest, 29000
Jérémie Théréaux, MD, +332 98 34 72 35, jeremie.thereaux@chu-brest.fr
Jérémie Théréaux, MD
- Not yet recruiting
Hôpital Côte de nacre, CHU Caen Normandie
Caen, 14000
Gil Lebreton, MD, +332.31.06.32.21, lebreton-g@chu-caen.fr
Gil Lebreton, MD
- Not yet recruiting
Hôpital Estang
Clermont-Ferrand, 63000
Olivier Antomarchi, MD, oantomarchi@chu-clermontferrand.fr
Olivier Antomarchi, MD
- Not yet recruiting
Hôpital Louis-Mourier, AP-HP
Colombes, 92700
David Moszkowicz, MD, +331 47 60 68 00, david.moszkowicz@aphp.fr
David Moszkowicz, MD
- Not yet recruiting
Hôpital Nord, CHU de Grenoble
La Tronche, 38700
Fabian Reche, MD, PhD, +334.76.76.88.84, Freche@chu-grenoble.fr
Fabian Reche, MD, PhD
- Not yet recruiting
Hôpital Claude Huriez, CHRU de Lille
Lille, 59000
Guillaume Piessen, MD, PhD, +333 20 44 55 06, guillaume.piessen@chru-lille.fr
Guillaume Piessen, MD, PhD
- Not yet recruiting
Polyclinique du bois, Hôpital privé Le Bois
Lille, 5900
Nicolas Briez, MD, +333.20.38.62.26, brieznico@msn.com
Nicolas Briez, MD
- Not yet recruiting
Hôpital Dupuytren 1, CHU de Limoges
Limoges, 87000
Muriel Mathonnet, MD, PhD, +335 55 05 67 13, mathonnet@unilim.fr
Muriel Mathonnet, MD, PhD
- Not yet recruiting
Hôpital de la Croix-Rousse, HCL
Lyon, 69000
Salim Mezoughi, MD, +334.72.07.11.00, salim.mezoughi@chu-lyon.fr
Salim Mezoughi, MD
- Not yet recruiting
Hôpital Saint Eloi, CHU de Montpellier
Montpellier, 34000
Jean-Michel Fabre, MD, PhD, +334.67.33.70.72, jm-fabre@chu-montpellier.fr
Jean-Michel Fabre, MD, PhD
- Not yet recruiting
Hôpital Hôtel Dieu, CHU de Nantes
Nantes, 44000
Claire Blanchard, MD, +332 76 64 37 98, Claire.BLANCHARD@chu-nantes.fr
Claire Blanchard, MD
- Not yet recruiting
Hôpital Archet, CHU de Nice
Nice, 06000
Antonio Ianelli, MD, PhD, +334.97.07.28.00, IANNELLI.A@chu-nice.fr
Antonio Ianelli, MD, PhD
- Not yet recruiting
Hôpital Saint-Louis, AP-HP
Paris, 75010
Hélène Corte, MD, helene.corte@aphp.fr
Hélène Corte, MD
- Not yet recruiting
Hôpital Saint-Antoine, AP-HP
Paris, 75012
Emmanuel Attal, MD, +331.49.28.25.47, emmanuelattal@orange.fr
Emmanuel Attal, MD
- Not yet recruiting
DMU SAPERE, CHU Pitié-Salpêtrière APHP
Paris, 75013
Laurent Genser, MD, +331 42 17 56 44, laurent.genser@aphp.fr
Laurent Genser, MD
- Not yet recruiting
Institut Mutualiste Montsouris
Paris, 75014
Stéphane Bonnet, MD, PhD, +331 56 61 67 12, stephane.bonnet@imm.fr
Stéphane Bonnet, MD, PhD
- Not yet recruiting
Hôpital Bichat, AP-HP
Paris, 75018
Simon Msika, MD, PhD, +331.40.25.69.03, simon.msika@aphp.fr
Simon Msika, MD, PhD
- Recruiting
Hôpital du Haut Lévêque
Pessac, 33600
Caroline Gronnier, MD, PhD, +335 57 65 60 05, caroline.gronnier@chu-bordeaux.fr
Caroline Gronnier, MD, PhD
- Not yet recruiting
Hôpital Jean-Bernard, CHU de Poitiers
Poitiers, 86000
Jean-Pierre Faure, MD, PhD, +335.49.44.43.21, j.p.faure@chu-poitiers.fr
Jean-Pierre Faure, MD, PhD
- Recruiting
CH René-Dubos
Pontoise, 95000
Nelson Trelles, MD, +331.30.75.40.22, nelsontrelles@gmail.com
Nelson Trelles, MD
- Not yet recruiting
CHU de Rennes, Site PONTCHAILLOU
Rennes, 35000
Damien Bergeat, MD, +332 99 28 43 21, damien.bergeat@chu-rennes.fr
Damien Bergeat, MD
- Not yet recruiting
Hôpital Charles Nicolle, CHU de Rouen
Rouen, 76000
Emmanuel Huet, MD, +332.32.88.85.72, emmanuel.huet@chu-rouen.fr
Emmanuel Huet, MD
- Not yet recruiting
Hôpital Felix-Guyon, CHU de la Réunion
Saint-Paul, 97415
Radwan Kassir, MD, +332 62 90 54 60, radwankassir42@hotmail.fr
Radwan Kassir, MD
- Not yet recruiting
Hôpital Rangueil, CHU de Toulouse
Toulouse, 31000
Nicolas Carrere, MD, +335.61.32.21.88, carrere.n@chu-toulouse.fr
Nicolas Carrere, MD
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Large Hiatal Hernia
- Being tested
- Laparoscopic hiatal hernia repair
- Keywords
- Large Hiatal Hernia, Recurrence, Surgery, Biosynthetic absorbable mesh
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hiatal hernia repairProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Biosynthetic absorbable mesh | Experimental | Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh Receives: Procedure: Laparoscopic hiatal hernia repair |
| No biosynthetic absorbable mesh | Sham comparator | Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh Receives: Procedure: Laparoscopic hiatal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Large Hiatal Hernia recurrence
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.
Measured: Month 24
Secondary outcomes (34)
Evaluation of Quality of life (QoL) by GIQLI,
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.
Measured: Day 0
Evaluation of Quality of life (QoL) by GIQLI,
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.
Measured: Month 1
Evaluation of Quality of life (QoL) by GIQLI,
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.
Measured: Month 6
Evaluation of Quality of life (QoL) by GIQLI,
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.
Measured: Month 12
Evaluation of Quality of life (QoL) by GIQLI,
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.
Measured: Month 24
Evaluation of Quality of life (QoL) by SF36 questionnaire
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.
Measured: Day 0
Evaluation of Quality of life (QoL) by SF36 questionnaire
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.
Measured: Month 1
Evaluation of Quality of life (QoL) by SF36 questionnaire
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.
Measured: Month 6
Evaluation of Quality of life (QoL) by SF36 questionnaire
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.
Measured: Month 12
Evaluation of Quality of life (QoL) by SF36 questionnaire
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.
Measured: Month 24
Evaluation of Quality of life (QoL) by EQ-5D-5L
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.
Measured: Day 0
Evaluation of Quality of life (QoL) by EQ-5D-5L
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.
Measured: Month 1
Evaluation of Quality of life (QoL) by EQ-5D-5L
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.
Measured: Month 6
Evaluation of Quality of life (QoL) by EQ-5D-5L
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.
Measured: Month 12
Evaluation of Quality of life (QoL) by EQ-5D-5L
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.
Measured: Month 24
Evaluation of Quality of life (QoL) by EQ-VAS
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).
Measured: Day 0
Evaluation of Quality of life (QoL) by EQ-VAS
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).
Measured: Month 1
Evaluation of Quality of life (QoL) by EQ-VAS
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).
Measured: Month 6
Evaluation of Quality of life (QoL) by EQ-VAS
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).
Measured: Month 12
Evaluation of Quality of life (QoL) by EQ-VAS
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).
Measured: Month 24
measurement of fever
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Measured: Month 1
measurement of fever
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Measured: Month 6
measurement of fever
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
Measured: Month 12
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
measuring fever with a thermometer
Measured: Month 24
measurement of weight
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Measured: Day 0
measurement of weight
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Measured: Month 1
measurement of weight
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Measured: Month 6
measurement of weight
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Measured: Month 12
measurement of weight
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
Measured: Month 24
measurement of blood pressure
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.
Measured: Day 0
measurement of blood pressure
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.
Measured: Month 1
measurement of blood pressure
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.
Measured: Month 6
measurement of blood pressure
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.
Measured: Month 12
measurement of blood pressure
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.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Jan 2024
- Primary completion18 Jan 2028 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Hiatal HerniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Gronnier, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867225
- Sponsor's protocol ID
- CHUBX 2021/23
- Acronym
- HIATUS
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05867225
- Acronym / sponsor ID
- HIATUS / CHUBX 2021/23
- Conditions
- Large Hiatal Hernia
- Keywords
- Large Hiatal Hernia, Recurrence, Surgery, Biosynthetic absorbable mesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 18 Jan 2028 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biosynthetic absorbable mesh | Experimental | Procedure: Laparoscopic hiatal hernia repairPatients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh |
| No biosynthetic absorbable mesh | Sham comparator | Procedure: Laparoscopic hiatal hernia repairPatients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic hiatal hernia repairlaparoscopic 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 | Procedure or surgery | Biosynthetic absorbable mesh, No biosynthetic absorbable mesh |
Primary outcome
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.
34 secondary outcomes
Evaluation of Quality of life (QoL) by GIQLI,
Time frame: Day 0
Evaluation of Quality of life (QoL) by GIQLI,
Time frame: Month 1
Evaluation of Quality of life (QoL) by GIQLI,
Time frame: Month 6
Evaluation of Quality of life (QoL) by GIQLI,
Time frame: Month 12
Evaluation of Quality of life (QoL) by GIQLI,
Time frame: Month 24
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time frame: Day 0
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time frame: Month 1
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time frame: Month 6
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time frame: Month 12
Evaluation of Quality of life (QoL) by SF36 questionnaire
Time frame: Month 24
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time frame: Day 0
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time frame: Month 1
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time frame: Month 6
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time frame: Month 12
Evaluation of Quality of life (QoL) by EQ-5D-5L
Time frame: Month 24
Evaluation of Quality of life (QoL) by EQ-VAS
Time frame: Day 0
Evaluation of Quality of life (QoL) by EQ-VAS
Time frame: Month 1
Evaluation of Quality of life (QoL) by EQ-VAS
Time frame: Month 6
Evaluation of Quality of life (QoL) by EQ-VAS
Time frame: Month 12
Evaluation of Quality of life (QoL) by EQ-VAS
Time frame: Month 24
measurement of fever
Time frame: Month 1
measurement of fever
Time frame: 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.
Time frame: Month 24
measurement of weight
Time frame: Day 0
measurement of weight
Time frame: Month 1
measurement of weight
Time frame: Month 6
measurement of weight
Time frame: Month 12
measurement of weight
Time frame: Month 24
measurement of blood pressure
Time frame: Day 0
measurement of blood pressure
Time frame: Month 1
measurement of blood pressure
Time frame: Month 6
measurement of blood pressure
Time frame: Month 12
measurement of blood pressure
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Gronnier, MD, PhD principal investigator
University Hospital, Bordeaux
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic hiatal hernia repair in people with Large Hiatal Hernia, run by University Hospital, Bordeaux at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Gronnier, MD, PhD (+ 33 5 57 65 60 05, caroline.gronnier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Large Hiatal Hernia recurrence (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.