Efficacy and patient satisfaction of single-session transoral incisionless fundoplication and laparoscopic hernia repair

Abstract

Background and aims Transoral incisionless fundoplication (TIF) is an effective endoscopic treatment for refractory GERD with small or absent hiatal hernia (< 2 cm in length and width). The single-session laparoscopic hernia repair followed by transoral incisionless fundoplication (HH + TIF) aims to repair mechanical defects in the lower esophageal sphincter that leads to GERD in patients with hiatal hernias ≥ 2 cm. The procedure effectively treats GERD without causing added postsurgical dysphagia and gas bloating commonly associated with partial laparoscopic fundoplication. We aimed to assess patient satisfaction, symptom resolution, safety, and proton pump inhibitor use following the HH + TIF procedure. Methods Thirty-three patients underwent single-session laparoscopic hernia repair with intraoperative TIF using the Eso-phyX Z device (EndoGastric Solutions, Inc.) between June 2015 and June 2018. The presence of GERD and normal esophageal motility were confirmed with pH testing and manometry prior to the procedure. Data were collected on pre-and post-procedure symptoms, patient satisfaction, PPI use, and complications. Median post-procedure follow-up with symptom surveys was 9 months (11-29 months). Results Patients reported significant decreases in common GERD symptoms including heartburn, regurgitation, cough, and hoarse voice. Eighty-one percent (27/33) of patients were off daily PPIs. Ninety-four percent (31/33) of patients reported 75% or greater satisfaction with the procedure and outcomes. One patient had a superficial mucosal laceration after the procedure, likely due to vomiting, which was treated conservatively. Conclusions The majority of patients reported 75% or greater satisfaction with the procedure and had an improvement in GERD symptoms as well as decreased PPI use. There were no serious adverse events.

Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: A retrospective study

“…Another study of 99 GERD patients with HH 2 to 5 cm undergoing this combined approach showed a considerable improvement in reflux symptoms with no long-term bloating or dysphagia, which are well-known side effects after LNF at 12 months 24 . A recent retrospective study of 33 patients also demonstrated that over 80 % of patients were off PPI, and over 90 % of patients achieved greater than 75 % satisfaction after this combined approach at a median follow-up of 9 months 25 . The U.S. Food and Drug Administration expanded the indication for TIF to use in patients with HH larger than 2 cm in whom laparoscopic HH repair is performed.…”

Minimally invasive endoscopic therapies for gastro-oesophageal reflux disease

“…TIF is being evaluated as an option for patients with larger hiatal hernias as part of a concomitant TIF/laparoscopic hiatal hernia repair. 26 Evidence base for TIF Several randomised controlled trials have evaluated the role of TIF 2.0 in the treatment of GORD. The RESPECT study was a randomised placebocontrolled trial comparing TIF to sham.…”

“…TIF 2.0 is suitable for patients with Hiatal hernia’s equal or less than 2 cm in size with a Hill grade equal or less than 2. TIF is being evaluated as an option for patients with larger hiatal hernias as part of a concomitant TIF/laparoscopic hiatal hernia repair 26…”

“…TIF is being evaluated as an option for patients with larger hiatal hernias as part of a concomitant TIF/laparoscopic hiatal hernia repair. 26 …”

The status of endoscopic therapies for gastroesophageal reflux disease

“…Most of the cTIF data comes from small retrospective series [17]. Idhe et al [18] first reported on 18 patients who underwent cTIF with improvement in GERD-HRQL scores and RSI score and no adverse events.…”