Actively Recruiting
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Led by University Hospital, Bordeaux · Updated on 2024-01-18
256
Participants Needed
26
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
CONDITIONS
Official Title
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoing laparoscopic primary repair for symptomatic large hiatal hernia (hernia >5 cm as diagnosed by imaging)
- Symptoms including heartburn, regurgitation, epigastric pain, difficulty swallowing, or anemia (other causes excluded)
- Age 18 years or older
- Affiliated with a social security system or beneficiary
- Signed written informed consent before any study-required examinations
You will not qualify if you...
- Undergoing reoperation for recurrent large hiatal hernia repair
- Emergency surgery needed within less than 6 hours
- Asymptomatic hiatal hernia
- American anesthesiologist score greater than 3
- Recurrent hiatal hernia or prior surgery involving gastroesophageal junction
- Brachyesophagus preventing sufficient intraabdominal esophagus length
- Previous major upper gastrointestinal surgery
- Unable to perform primary closure of the diaphragm crura
- Pregnant or breastfeeding women
- Persons deprived of liberty, under guardianship, or unable to consent
- Psychological, social, or geographic factors limiting protocol compliance or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
CH de la Côte Basque
Bayonne, France, 64100
Not Yet Recruiting
2
Hôpital Jean Minjoz, CHRU de Besançon
Besançon, France, 25000
Not Yet Recruiting
3
Hôpital Cavale blanche, CHRU de Brest
Brest, France, 29000
Not Yet Recruiting
4
Hôpital Côte de nacre, CHU Caen Normandie
Caen, France, 14000
Not Yet Recruiting
5
Hôpital Estang
Clermont-Ferrand, France, 63000
Not Yet Recruiting
6
Hôpital Louis-Mourier, AP-HP
Colombes, France, 92700
Not Yet Recruiting
7
Hôpital Nord, CHU de Grenoble
La Tronche, France, 38700
Not Yet Recruiting
8
Hôpital Claude Huriez, CHRU de Lille
Lille, France, 59000
Not Yet Recruiting
9
Polyclinique du bois, Hôpital privé Le Bois
Lille, France, 5900
Not Yet Recruiting
10
Hôpital Dupuytren 1, CHU de Limoges
Limoges, France, 87000
Not Yet Recruiting
11
Hôpital de la Croix-Rousse, HCL
Lyon, France, 69000
Not Yet Recruiting
12
Hôpital Saint Eloi, CHU de Montpellier
Montpellier, France, 34000
Not Yet Recruiting
13
Hôpital Hôtel Dieu, CHU de Nantes
Nantes, France, 44000
Not Yet Recruiting
14
Hôpital Archet, CHU de Nice
Nice, France, 06000
Not Yet Recruiting
15
Hôpital Saint-Louis, AP-HP
Paris, France, 75010
Not Yet Recruiting
16
Hôpital Saint-Antoine, AP-HP
Paris, France, 75012
Not Yet Recruiting
17
DMU SAPERE, CHU Pitié-Salpêtrière APHP
Paris, France, 75013
Not Yet Recruiting
18
Institut Mutualiste Montsouris
Paris, France, 75014
Not Yet Recruiting
19
Hôpital Bichat, AP-HP
Paris, France, 75018
Not Yet Recruiting
20
Hôpital du Haut Lévêque
Pessac, France, 33600
Actively Recruiting
21
Hôpital Jean-Bernard, CHU de Poitiers
Poitiers, France, 86000
Not Yet Recruiting
22
CH René-Dubos
Pontoise, France, 95000
Actively Recruiting
23
CHU de Rennes, Site PONTCHAILLOU
Rennes, France, 35000
Not Yet Recruiting
24
Hôpital Charles Nicolle, CHU de Rouen
Rouen, France, 76000
Not Yet Recruiting
25
Hôpital Felix-Guyon, CHU de la Réunion
Saint-Paul, France, 97415
Not Yet Recruiting
26
Hôpital Rangueil, CHU de Toulouse
Toulouse, France, 31000
Not Yet Recruiting
Research Team
C
Caroline Gronnier, MD, PhD
CONTACT
V
Valérie Aurillac-Lavignolle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here