Peter Janu MD1, Ahmad Bassel Shughoury MD2, Kumar Venkat MD2, Daniel Hurwich MD2, Tom Galouzis MD2, James Siatras MD2, Dennis Streeter DO2, Kathleen Korman RN2, G
1Affinity Health Systems Appleton, Wisconsin & 2Methodist Hospitals, Merrillville Indiana
GERD unresponsive to medical therapies can be treated by laparoscopic Nissen fundoplication or endoluminal techniques. We describe our experience using the TIF procedure with the EsophyX device. The TIF procedure is not indicated in patients with a hiatal hernia larger than 2 cm. Performing a hiatal hernia repair (HHR) in those cases will make a patient eligible for a TIF procedure. 1 HHR followed immediately by the TIF procedure under the same anesthetic session is called a Hybrid-TIF (HTIF). This study examines the safety and efficacy of this approach.
Prospective data were collected from patients who underwent HTIF at two 300-bed community hospitals. Questionnaires were administered before the procedure, and mailed at 6- and 12-months post concomitant procedure. They were:
- GERD-Health Related Quality of Life (GERD-HRQL)2
- Reflux Symptom Index (RSI) 3
- GERD Symptom Score (GSRS) 4
At site 1 the same surgeon (PJ) performed HTIF. At site 2 three general surgeons (TG, JS, DS) performed HHR and four gastroenterologists (PM, BS, DH, KV) performed the TIF procedures.
Ninety-nine patients were enrolled, 49 from site 1, 50 from site 2. All were symptomatic on PPI medications with hiatal hernias between 2 and 5 cm. The avg. age was 53, 56% female, and avg. BMI was 30. The questionnaire response rate was 73% at 6 mos., 67% at 12 mos., and 48% for both. Heartburn severity score (1-5) dropped from 2.95 to .45 at 6 mos. and .52 at 12 mos.
Other GERD-HRQL scores were improved 85% for all six heartburn questions and 7 regurgitation questions, while 50% improvement was noted for bloating, dysphagia and odynophagia.
The atypical symptoms from the RSI scores for chest pain dropped from 3.42 to .72 at 6 mos. and .47 at 12 mos. Hoarseness, throat clearing, excess mucus, coughing, also improved as well, from 50% to 80%.
The GSRS questions on heartburn dropped from 2.85 to .48 at 6 mos. and .42 at 12 mos. and regurgitation showed 80% improvement while bloating and dysphagia improved by more than 50%.
All these results were durable at 6 and 12 mos. All measures were statistically improved at p<0.05. There were no adverse effects reported.
TIF procedures can be safely performed immediately following HHR. Excellent symptom control occurred for heartburn and regurgitation with no long-term dysphagia or bloating. Most patients reported durable symptom control at 1 year post intervention. Similar results were obtained with either one operator (surgeon) performing both steps of the procedure or surgeons and gastroenterologists working as a team.
1Ihde GM, Besancon K, Deljkich E. Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with or without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg. 2011 Dec; 202(6):740-7.
2Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 2007 20:130-134
3Belafsky PC, Postma GN, Koufman JA Validity and reliability of the reflux symptom index (RSI). Journal of Voice 2002 16.2:274-9
4Allen CJ, Parameswaran K, Belda J, Anvari M; Reproducibility, validity and responsiveness of a disease-speciﬁc symptom questionnaire for gastroesophageal reﬂux disease. Dis Esophagus 2000 13: 265–270