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Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up (PRIME LTFU)

Primary Purpose

Hernia, Hiatal, Laparoscopic, Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mesh repair
Suture repair
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Hiatal

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant of the initial PRIME study Alive Exclusion Criteria: No informed consent Additional hiatal hernia repair surgery during the follow-up period Pregnancy Patients that have stated they do not want to be approached for follow-up research

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Non-absorbable sutures

    Non-absorbable sutures and a TiMESH®

    Arm Description

    The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures

    The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair.

    Outcomes

    Primary Outcome Measures

    Percentage of objective recurrence of a hiatal hernia
    Objective measurement of the integrity of the hiatal hernia repair by CT-imaging

    Secondary Outcome Measures

    Percentage of clinical recurrence of a hiatal hernia
    Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
    Symptoms of gastroesophageal reflux disease
    Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
    Patient satisfaction
    Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'.

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    December 15, 2022
    Sponsor
    Rijnstate Hospital
    Collaborators
    Rijnstate Vriendenfonds
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05662735
    Brief Title
    Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
    Acronym
    PRIME LTFU
    Official Title
    Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rijnstate Hospital
    Collaborators
    Rijnstate Vriendenfonds

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Hiatal, Laparoscopic, Surgery, Recurrence, Mesh, Primary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomised controlled trial
    Masking
    Participant
    Masking Description
    Patients were blinded for repair with sutures alone or sutures with mesh augmentation
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-absorbable sutures
    Arm Type
    Active Comparator
    Arm Description
    The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures
    Arm Title
    Non-absorbable sutures and a TiMESH®
    Arm Type
    Active Comparator
    Arm Description
    The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair.
    Intervention Type
    Device
    Intervention Name(s)
    Mesh repair
    Intervention Description
    Augmentation of hiatal hernia repair with TiMESH® reinforcement
    Intervention Type
    Procedure
    Intervention Name(s)
    Suture repair
    Intervention Description
    Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
    Primary Outcome Measure Information:
    Title
    Percentage of objective recurrence of a hiatal hernia
    Description
    Objective measurement of the integrity of the hiatal hernia repair by CT-imaging
    Time Frame
    5-10 years
    Secondary Outcome Measure Information:
    Title
    Percentage of clinical recurrence of a hiatal hernia
    Description
    Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
    Time Frame
    5-10 years
    Title
    Symptoms of gastroesophageal reflux disease
    Description
    Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
    Time Frame
    5-10 years
    Title
    Patient satisfaction
    Description
    Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'.
    Time Frame
    5-10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant of the initial PRIME study Alive Exclusion Criteria: No informed consent Additional hiatal hernia repair surgery during the follow-up period Pregnancy Patients that have stated they do not want to be approached for follow-up research
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier Bouwmeester, MSc
    Phone
    088 - 005 8888
    Email
    obouwmeester@rijnstate.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up

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