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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.
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 :
The expected benefits are :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biosynthetic absorbable mesh | Experimental | Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh |
|
| No biosynthetic absorbable mesh | Sham Comparator | Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic hiatal hernia repair | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Evaluation of Quality of life (QoL) by GIQLI, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Gronnier, MD, PhD | Contact | + 33 5 57 65 60 05 | caroline.gronnier@chu-bordeaux.fr | |
| Valérie Aurillac-Lavignolle | Contact | +33 5 57 82 24 77 | valerie.aurillac@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Gronnier, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de la Côte Basque | Not yet recruiting | Bayonne | 64100 | France |
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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, | 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, | 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, | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C. | Month 1 |
| measurement of fever | measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C. | Month 6 |
| measurement of fever | 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. | measuring fever with a thermometer | Month 24 |
| measurement of weight | Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150 | Day 0 |
| measurement of weight | Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150 | Month 1 |
| measurement of weight | Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150 | Month 6 |
| measurement of weight | Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150 | Month 12 |
| measurement of weight | Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150 | 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. | 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. | 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. | 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. | 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. | Month 24 |
| Hôpital Jean Minjoz, CHRU de Besançon | Not yet recruiting | Besançon | 25000 | France |
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| Hôpital Cavale blanche, CHRU de Brest | Not yet recruiting | Brest | 29000 | France |
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| Hôpital Côte de nacre, CHU Caen Normandie | Not yet recruiting | Caen | 14000 | France |
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| Hôpital Estang | Not yet recruiting | Clermont-Ferrand | 63000 | France |
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| Hôpital Louis-Mourier, AP-HP | Not yet recruiting | Colombes | 92700 | France |
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| Hôpital Nord, CHU de Grenoble | Not yet recruiting | La Tronche | 38700 | France |
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| Hôpital Claude Huriez, CHRU de Lille | Not yet recruiting | Lille | 59000 | France |
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| Polyclinique du bois, Hôpital privé Le Bois | Not yet recruiting | Lille | 5900 | France |
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| Hôpital Dupuytren 1, CHU de Limoges | Not yet recruiting | Limoges | 87000 | France |
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| Hôpital de la Croix-Rousse, HCL | Not yet recruiting | Lyon | 69000 | France |
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| Hôpital Saint Eloi, CHU de Montpellier | Not yet recruiting | Montpellier | 34000 | France |
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| Hôpital Hôtel Dieu, CHU de Nantes | Not yet recruiting | Nantes | 44000 | France |
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| Hôpital Archet, CHU de Nice | Not yet recruiting | Nice | 06000 | France |
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| Hôpital Saint-Louis, AP-HP | Not yet recruiting | Paris | 75010 | France |
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| Hôpital Saint-Antoine, AP-HP | Not yet recruiting | Paris | 75012 | France |
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| DMU SAPERE, CHU Pitié-Salpêtrière APHP | Not yet recruiting | Paris | 75013 | France |
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| Institut Mutualiste Montsouris | Not yet recruiting | Paris | 75014 | France |
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| Hôpital Bichat, AP-HP | Not yet recruiting | Paris | 75018 | France |
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| Hôpital du Haut Lévêque | Recruiting | Pessac | 33600 | France |
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| Hôpital Jean-Bernard, CHU de Poitiers | Not yet recruiting | Poitiers | 86000 | France |
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| CH René-Dubos | Recruiting | Pontoise | 95000 | France |
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| CHU de Rennes, Site PONTCHAILLOU | Not yet recruiting | Rennes | 35000 | France |
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| Hôpital Charles Nicolle, CHU de Rouen | Not yet recruiting | Rouen | 76000 | France |
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| Hôpital Felix-Guyon, CHU de la Réunion | Not yet recruiting | Saint-Paul | 97415 | France |
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| Hôpital Rangueil, CHU de Toulouse | Not yet recruiting | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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