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Background: Preoperative hiatal hernia ≥3 cm is associated with a threefold relative risk for reflux symptom recurrence after fundoplication without mesh. This report assesses the short-term safety and efficacy of ePTFE mesh used for repair of herniae ≥3 cm in length in Nissen fundoplication for samptomatic reflux.
Patients and methods. 22 Patients with gastroesophageal reflux disease and typical symptoms responding at least in part to PPI therapy were entered into a pilot study. Inclusion criteria comprised also endoscopic evidence of erosions and/or abnormal esophageal acid exposure, and a hiatal hernia of ≥3 cm in length. Study endpoints were the time to recurrence of reflux symptoms and the postoperative incidence of dysphagia with ensuing intervention. A cohort of 45 patients having undergone fundoplication without mesh for reflux with hiatal hernia from 1996-2007, who have been carefully audited for symptom recurrence served as a comparison group. The study population underwent Nissen fundoplication with tension free repair of the hiatus using a Goretex® dual mesh in inlay technique secured by single non-absorbable sutures. The patients were contacted at 1,3, and 6 months postop, and 6 monthly therafter. A symptom recurrence was defined by heartburn and/or regurgitation more frequently than once a week and/or the need for PPI treatment to control reflux symptoms. A significant dysphagia was defined as swallowing difficulites severe enough that the patient accepted an offered intervention: endoscopy or endoscopic dilatation. The patient characteristics are shown in Table1.
Results: No conversions, revisions, or reoperations were suffered in the study group. Following a mean follow-up of 18 +/-12 months no symptom recurrences were encountered in the study group. Two patients reported dysphagia, in one resolved after endoscopy, the other requiring two dilatations. The Weibull parametric analysis of symptom free survival revealed a borderline significant (p=0.09) influence in favor of of mesh and the recurrence rate estimates in the control group as follows: 1 year: 5%, 3 years 12 %, and 5 years: 30 %.
Comment: ePTFE mesh for narrowing the hiatus in hiatal hernia repair with Nissen Fundoplication seems safe and effective. The difference in recurrence rates as compared to a historical control group with otherwise identical operative technique is not (yet?) significant. If the promising results should sustain, inlay application in hiatal hernia should be proficient to further improve the performance of fundoplication.
Patients and results

Variable	Mesh (n=22)	Controls (n=45)
Age	54(34-70)	57(27-74)
Gender(M:F ratio)	1.1	2.5
Hiatal hernia (cm)	5 (3-8)	5(3-10)
Sympt recurrences	0/22	13/45 (29%)
Overall follow-up	15 mo (2 - 44)	115 mo (12 - 183)
Time to recurrence	..	32 mo (10-115)

Symptom recurrence rates

	Estimated	rate of	recurrence
	12 mo	36 mo	120 mo
No mesh	5%	12%	30%
PTFE	0	..	..