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

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ClinicalTrials.gov Identifier: NCT05867225
Recruitment Status : Recruiting
First Posted : May 19, 2023
Last Update Posted : January 18, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE December 30, 2022
First Posted Date  ICMJE May 19, 2023
Last Update Posted Date January 18, 2024
Actual Study Start Date  ICMJE January 15, 2024
Estimated Primary Completion Date January 18, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2023)
  • Evaluation of Quality of life (QoL) by GIQLI, [ Time Frame: 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, [ Time Frame: 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, [ Time Frame: 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, [ Time Frame: 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, [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Month 1 ]
    measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
  • measurement of fever [ Time Frame: Month 6 ]
    measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.
  • 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.
  • measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C. [ Time Frame: Month 24 ]
    measuring fever with a thermometer
  • measurement of weight [ Time Frame: Day 0 ]
    Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
  • measurement of weight [ Time Frame: Month 1 ]
    Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
  • measurement of weight [ Time Frame: Month 6 ]
    Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
  • measurement of weight [ Time Frame: Month 12 ]
    Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
  • measurement of weight [ Time Frame: Month 24 ]
    Measuring weight loss with a scale.The unit is kilogram. Weight change is between 30 and 150
  • measurement of blood pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Large Hiatal Hernia
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Biosynthetic absorbable mesh
    Patients who have undergone hiatal surgery with use of a biosynthetic absorbable mesh
    Intervention: Procedure: Laparoscopic hiatal hernia repair
  • Sham Comparator: No biosynthetic absorbable mesh
    Patients who have undergone hiatal surgery without use of a biosynthetic absorbable mesh
    Intervention: Procedure: Laparoscopic hiatal hernia repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2023)		 256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 18, 2028
Estimated Primary Completion Date January 18, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Caroline Gronnier, MD, PhD + 33 5 57 65 60 05 caroline.gronnier@chu-bordeaux.fr
Contact: Valérie Aurillac-Lavignolle +33 5 57 82 24 77 valerie.aurillac@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05867225
Other Study ID Numbers  ICMJE CHUBX 2021/23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caroline Gronnier, MD, PhD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP