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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05867225

Collaborator

(none)

256

Enrollment

Locations

Arms

Anticipated Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Large Hiatal Hernia	Procedure: Laparoscopic hiatal hernia repair	N/A

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.

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

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of Large Hiatal Hernia recurrence [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.

Secondary Outcome Measures

Evaluation of Quality of life (QoL) by GIQLI, [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.
Evaluation of Quality of life (QoL) by GIQLI, [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.
Evaluation of Quality of life (QoL) by GIQLI, [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.
Evaluation of Quality of life (QoL) by GIQLI, [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.
Evaluation of Quality of life (QoL) by GIQLI, [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.
Evaluation of Quality of life (QoL) by SF36 questionnaire [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.
Evaluation of Quality of life (QoL) by SF36 questionnaire [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.
Evaluation of Quality of life (QoL) by SF36 questionnaire [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.
Evaluation of Quality of life (QoL) by SF36 questionnaire [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.
Evaluation of Quality of life (QoL) by SF36 questionnaire [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.
Evaluation of Quality of life (QoL) by EQ-5D-5L [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.
Evaluation of Quality of life (QoL) by EQ-5D-5L [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.
Evaluation of Quality of life (QoL) by EQ-5D-5L [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.
Evaluation of Quality of life (QoL) by EQ-5D-5L [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.
Evaluation of Quality of life (QoL) by EQ-5D-5L [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.
Evaluation of Quality of life (QoL) by EQ-VAS [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).
Evaluation of Quality of life (QoL) by EQ-VAS [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).
Evaluation of Quality of life (QoL) by EQ-VAS [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).
Evaluation of Quality of life (QoL) by EQ-VAS [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).
Evaluation of Quality of life (QoL) by EQ-VAS [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).
measurement of fever [Month 1]
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
measurement of fever [Month 6]
measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
measurement of fever [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.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C. [Month 24]
measuring fever with a thermometer
measurement of weight [Day 0]
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
measurement of weight [Month 1]
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
measurement of weight [Month 6]
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
measurement of weight [Month 12]
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
measurement of weight [Month 24]
Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
measurement of blood pressure [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.
measurement of blood pressure [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.
measurement of blood pressure [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.
measurement of blood pressure [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.
measurement of blood pressure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH de la Côte Basque	Bayonne	France	64100
2	Hôpital Jean Minjoz, CHRU de Besançon	Besançon	France	25000
3	Hôpital Cavale blanche, CHRU de Brest	Brest	France	29000
4	Hôpital Côte de nacre, CHU Caen Normandie	Caen	France	14000
5	Hôpital Estang	Clermont-Ferrand	France	63000
6	Hôpital Louis-Mourier, AP-HP	Colombes	France	92700
7	Hôpital Nord, CHU de Grenoble	La Tronche	France	38700
8	Hôpital Claude Huriez, CHRU de Lille	Lille	France	59000
9	Polyclinique du bois, Hôpital privé Le Bois	Lille	France	5900
10	Hôpital Dupuytren 1, CHU de Limoges	Limoges	France	87000
11	Hôpital de la Croix-Rousse, HCL	Lyon	France	69000
12	Hôpital Saint Eloi, CHU de Montpellier	Montpellier	France	34000
13	Hôpital Hôtel Dieu, CHU de Nantes	Nantes	France	44000
14	Hôpital Archet, CHU de Nice	Nice	France	06000
15	Hôpital Saint-Louis, AP-HP	Paris	France	75010
16	Hôpital Saint-Antoine, AP-HP	Paris	France	75012
17	DMU SAPERE, CHU Pitié-Salpêtrière APHP	Paris	France	75013
18	Institut Mutualiste Montsouris	Paris	France	75014
19	Hôpital Bichat, AP-HP	Paris	France	75018
20	Hôpital du Haut Lévêque	Pessac	France	33600
21	Hôpital Jean-Bernard, CHU de Poitiers	Poitiers	France	86000
22	CH René-Dubos	Pontoise	France	95000
23	CHU de Rennes, Site PONTCHAILLOU	Rennes	France	35000
24	Hôpital Charles Nicolle, CHU de Rouen	Rouen	France	76000
25	Hôpital Felix-Guyon, CHU de la Réunion	Saint Paul	France	97415
26	Hôpital Rangueil, CHU de Toulouse	Toulouse	France	31000