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Clinical Trials/NL-OMON48062
NL-OMON48062
Recruiting
Not Applicable

Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Circular Bio-absorbable Hiatal Mesh Reinforcement in Hiatal Hernia Repair - PRIME-II trial

Isala Klinieken0 sites220 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Isala Klinieken
Enrollment
220
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Isala Klinieken

Eligibility Criteria

Inclusion Criteria

  • •\- Age \> 18 years
  • •\- Hiatus hernia type II\-IV
  • •\- Laparoscopic surgical repair clinically indicated
  • •\- Fit for surgery
  • •\- Suitable for both procedures

Exclusion Criteria

  • •\- Age \< 18 years
  • •\- Hiatus hernia type I.
  • •\- No informed consent
  • •\- Previous anti\-reflux surgery or repair for hiatus hernia
  • •\- Pregnancy
  • •\- Achalasia

Outcomes

Primary Outcomes

Not specified

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