CTIF vs LNF for Acid Reflux
(CTIF Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial compares two treatments, TIF and LNF, for patients with acid reflux and a hiatal hernia who are having hernia repair surgery. TIF is a non-surgical procedure done through the mouth, while LNF is a minimally invasive surgery. Both aim to stop acid reflux by improving the valve between the stomach and esophagus.

Eligibility Criteria

This trial is for adults aged 22-80 with GERD and a hiatal hernia smaller than 5 cm, who have not had previous anti-reflux surgery. Participants must show signs of acid reflux, be able to consent, and commit to the study long-term. Those with severe gastroparesis, large hernias over 5 cm, significant esophageal disorders, or women who are pregnant cannot join.

Inclusion Criteria

You are willing to participate in the study for a long period of time.

I have severe GERD and a small hiatal hernia.

Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.

+5 more

Exclusion Criteria

I have had surgery to prevent acid reflux.

You need to have a surgery that involves using a mesh implant at the same time as the study.

At the discretion of the site PI for subject safety

+6 more

Participant Groups

The study compares two treatments for GERD in patients needing hiatal hernia repair: Laparoscopic Hiatal Hernia Repair combined with Transoral Incisionless Fundoplication (TIF) versus standard Laparoscopic Nissen Fundoplication (LNF). Patients will be randomly assigned to either treatment at multiple centers.

2Treatment groups

Active Control

Group I: Combo Transoral Incisionless Fundoplication (CTIF)Active Control1 Intervention

Treatment

Group II: Laparoscopic Nissen Fundoplication (LNF)Active Control1 Intervention

Control