The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05662735
Recruitment Status : Not yet recruiting
First Posted : December 22, 2022
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
Rijnstate Vriendenfonds
Information provided by (Responsible Party):
Rijnstate Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.

Condition or disease Intervention/treatment Phase
Hernia, Hiatal Laparoscopic Surgery Recurrence Mesh Primary Device: Mesh repair Procedure: Suture repair Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled trial
Masking: Single (Participant)
Masking Description: Patients were blinded for repair with sutures alone or sutures with mesh augmentation
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Non-absorbable sutures
The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures
 Procedure: Suture repair
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures
Active Comparator: Non-absorbable sutures and a TiMESH®
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.
 Device: Mesh repair
Augmentation of hiatal hernia repair with TiMESH® reinforcement

Procedure: Suture repair
Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of objective recurrence of a hiatal hernia [ Time Frame: 5-10 years ]
    Objective measurement of the integrity of the hiatal hernia repair by CT-imaging


Secondary Outcome Measures :
  1. Percentage of clinical recurrence of a hiatal hernia [ Time Frame: 5-10 years ]
    Recurrence of symptoms related to a hiatal hernia measured by a questionnaire

  2. Symptoms of gastroesophageal reflux disease [ Time Frame: 5-10 years ]
    Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire

  3. Patient satisfaction [ Time Frame: 5-10 years ]
    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'.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05662735


Contacts
Layout table for location contacts
Contact: Olivier Bouwmeester, MSc 088 - 005 8888 obouwmeester@rijnstate.nl

Sponsors and Collaborators
Rijnstate Hospital
Rijnstate Vriendenfonds
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT05662735    
Other Study ID Numbers: NL82840.100.22
First Posted: December 22, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Recurrence
Hernia, Hiatal
Pathological Conditions, Anatomical
 Disease Attributes
Pathologic Processes
Hernia, Diaphragmatic
Internal Hernia