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

Surgery Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05662735
• Other study ID #: NL82840.100.22
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2023
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Rijnstate Hospital
• Contact: Olivier Bouwmeester, MSc
• Phone: 088 - 005 8888
• Email: obouwmeester[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Laparoscopic
• Primary
• Recurrence
• Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Rijnstate Vriendenfonds

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of objective recurrence of a hiatal hernia	Objective measurement of the integrity of the hiatal hernia repair by CT-imaging	5-10 years
Secondary	Percentage of clinical recurrence of a hiatal hernia	Recurrence of symptoms related to a hiatal hernia measured by a questionnaire	5-10 years
Secondary	Symptoms of gastroesophageal reflux disease	Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire	5-10 years
Secondary	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'.	5-10 years