Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Launched by MAYO CLINIC · Mar 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical treatments for patients with gastroesophageal reflux disease (GERD) who also have a hiatal hernia, which is when part of the stomach pushes up through the diaphragm into the chest. The trial compares a procedure called Transoral Incisionless Fundoplication (TIF) with Laparoscopic Nissen Fundoplication (LNF) to see which one is more effective and safer for patients undergoing surgery to fix their hiatal hernia. The study involves 142 participants across seven different locations and is currently active but not recruiting new patients.

To be eligible for this trial, participants must be between 22 and 80 years old and have a hiatal hernia that is less than 5 cm in size, along with certain types of reflux symptoms that have not improved with medication. Individuals who have had previous surgeries on their stomach or have other specific health issues may not qualify. If someone is selected to participate, they will undergo one of the two surgical procedures and will be expected to commit to follow-up visits to assess their recovery and symptoms over time. This trial will provide valuable information that could help improve treatment options for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 22-80 years of age
• • 2. Subjects have GERD with hiatal hernia \< 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
• 3. Pathologic reflux while off PPI based on Lyon criteria by either of the following:
• • 3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis.
• • 3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
• • 4. Commitment to long-term study
• • 5. Ability to give consent individually or by a legally authorized representative
• Exclusion Criteria:
• • 1. Hiatal hernia \> 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery)
• • 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
• • 3. Pregnancy (in females) at time of procedure
• • 4. Previous anti-reflux procedure
• • 5. Subjects requiring mesh treatment at time of procedure
• • 6. At the discretion of the site PI for subject safety
• • 7. BMI \> 35 at time of surgery.
• • 8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
• • 9. Severe gastroparesis