NCT05867225

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

December 30, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2028

Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

December 30, 2022

Last Update Submit

January 17, 2024

Conditions

Large Hiatal Hernia

Keywords

Large Hiatal HerniaRecurrenceSurgeryBiosynthetic absorbable mesh

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (34)

  • Evaluation of Quality of life (QoL) by GIQLI,

    Day 0

  • Evaluation of Quality of life (QoL) by GIQLI,

    Month 1

  • Evaluation of Quality of life (QoL) by GIQLI,

    Month 6

  • Evaluation of Quality of life (QoL) by GIQLI,

    Month 12

  • Evaluation of Quality of life (QoL) by GIQLI,

    Month 24

  • +29 more secondary outcomes

Study Arms (2)

Biosynthetic absorbable mesh

EXPERIMENTAL

Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh

Procedure: Laparoscopic hiatal hernia repair

No biosynthetic absorbable mesh

SHAM COMPARATOR

Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh

Procedure: Laparoscopic hiatal hernia repair

Interventions

Laparoscopic hiatal hernia repairPROCEDURE

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

Biosynthetic absorbable meshNo biosynthetic absorbable mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patient aged ≥ 18 years;
  • Patient affiliated to a social security system or beneficiary of the same;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CH de la Côte Basque

Bayonne, 64100, France

NOT YET RECRUITING

Hôpital Jean Minjoz, CHRU de Besançon

Besançon, 25000, France

NOT YET RECRUITING

Hôpital Cavale blanche, CHRU de Brest

Brest, 29000, France

NOT YET RECRUITING

Hôpital Côte de nacre, CHU Caen Normandie

Caen, 14000, France

NOT YET RECRUITING

Hôpital Estang

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Hôpital Louis-Mourier, AP-HP

Colombes, 92700, France

NOT YET RECRUITING

Hôpital Nord, CHU de Grenoble

La Tronche, 38700, France

NOT YET RECRUITING

Hôpital Claude Huriez, CHRU de Lille

Lille, 59000, France

NOT YET RECRUITING

Polyclinique du bois, Hôpital privé Le Bois

Lille, 5900, France

NOT YET RECRUITING

Hôpital Dupuytren 1, CHU de Limoges

Limoges, 87000, France

NOT YET RECRUITING

Hôpital de la Croix-Rousse, HCL

Lyon, 69000, France

NOT YET RECRUITING

Hôpital Saint Eloi, CHU de Montpellier

Montpellier, 34000, France

NOT YET RECRUITING

Hôpital Hôtel Dieu, CHU de Nantes

Nantes, 44000, France

NOT YET RECRUITING

Hôpital Archet, CHU de Nice

Nice, 06000, France

NOT YET RECRUITING

Hôpital Saint-Louis, AP-HP

Paris, 75010, France

NOT YET RECRUITING

Hôpital Saint-Antoine, AP-HP

Paris, 75012, France

NOT YET RECRUITING

DMU SAPERE, CHU Pitié-Salpêtrière APHP

Paris, 75013, France

NOT YET RECRUITING

Institut Mutualiste Montsouris

Paris, 75014, France

NOT YET RECRUITING

Hôpital Bichat, AP-HP

Paris, 75018, France

NOT YET RECRUITING

Hôpital du Haut Lévêque

Pessac, 33600, France

RECRUITING

Hôpital Jean-Bernard, CHU de Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

CH René-Dubos

Pontoise, 95000, France

RECRUITING

CHU de Rennes, Site PONTCHAILLOU

Rennes, 35000, France

NOT YET RECRUITING

Hôpital Charles Nicolle, CHU de Rouen

Rouen, 76000, France

NOT YET RECRUITING

Hôpital Felix-Guyon, CHU de la Réunion

Saint-Paul, 97415, France

NOT YET RECRUITING

Hôpital Rangueil, CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline Gronnier, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Gronnier, MD, PhD

CONTACT

+ 33 5 57 65 60 05caroline.gronnier@chu-bordeaux.fr

Valérie Aurillac-Lavignolle

CONTACT

+33 5 57 82 24 77valerie.aurillac@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

May 19, 2023

Study Start

January 15, 2024

Primary Completion (Estimated)

January 18, 2028

Study Completion (Estimated)

January 18, 2028

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(26)