By InvitationNot Applicable

Fundoplication in Laparoscopic PEH Repair Based on FLIP

United States260 participantsStarted 2023-02-22

Plain-language summary

Prospective randomized controlled trial to identify a sub-set of patients that do not benefit from the routine addition, and added morbidity, of a fundoplication during laparoscopic paraesophageal hernia repair.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing laparoscopic paraesophageal hernia repair Exclusion Criteria: * History of a prior hiatal hernia/paraesophageal hernia repair * Patients with objective GERD preoperatively * Intra-operative short esophagus * Defective gastroesophageal reflux barrier as determined by impedance planimetry (FLIP) * Defective gastroesophageal reflux barrier as determined by intra-operative endoscopy

What they're measuring

Number of participants with GERD post-op

Timeframe: 12 months

Trial details

NCT IDNCT05807763

SponsorThe Foundation for Surgical Innovation and Education

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-22

View on ClinicalTrials.gov More Paraesophageal Hernia trials