CTIF vs LNF for Acid Reflux
(CTIF Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have pathologic reflux while off PPI (a type of medication for acid reflux), which suggests you may need to stop taking PPIs before the trial.
How does the treatment Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF) differ from other treatments for acid reflux?
This treatment is unique because it combines a laparoscopic repair of the hiatal hernia (a condition where part of the stomach pushes up through the diaphragm) with transoral incisionless fundoplication (TIF), an endoscopic procedure that doesn't require incisions. This approach is associated with fewer early and serious adverse events compared to the traditional laparoscopic Nissen fundoplication (LNF), and it may result in a shorter hospital stay and less bloating.12345
What data supports the effectiveness of the treatment Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF) for acid reflux?
Research shows that combining hiatal hernia repair with TIF significantly improves symptoms of acid reflux, such as heartburn and regurgitation, with most patients experiencing effective symptom control and reduced medication use at 12 months. This approach also has fewer early and serious adverse events compared to traditional methods.12467
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either Combo Transoral Incisionless Fundoplication (CTIF) or Laparoscopic Nissen Fundoplication (LNF) for treatment of GERD with hiatal hernia repair
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of esophagitis healing, PPI use cessation, and recurrence of hiatal hernia
What Are the Treatments Tested in This Trial?
Interventions
- Laparoscopic Paraesophageal Hiatal Hernia Repair Combined with Transoral Incisionless Fundoplication (TIF)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
EndoGastric Solutions
Industry Sponsor
The University of Texas Health Science Center, Houston
Collaborator
Fox Valley Surgical Associates
Collaborator
University of California, Irvine
Collaborator
University of Texas at Austin
Collaborator
University of Southern California
Collaborator
Institute of Esophageal and Reflux Surgery
Collaborator