Repair of XXXX -Is a Fundoplication Needed? A Randomized Controlled Pilot Trial.

@entity1 @entity2910 @entity260 @entity357 @entity86 @entity354 @entity1282
BACKGROUND: The need for a fundoplication during repair of @entity357 ( @entity357 ) remains unclear. Prevention of @entity354 represents a trade-off against the risk of fundoplication-related side effects. The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy (LMAH-C) with laparoscopic mesh-augmented hiatoplasty with fundoplication (LMAH-F) in @entity1 with @entity357 . STUDY DESIGN: The study was designed as a @entity1 - and assessor-blinded randomized controlled pilot trial, registration number: DRKS00004492 (www.germanctr.de/). @entity1 with symptomatic @entity357 were eligible and assigned by central randomization to LMAH-C or LMAH-F. Endpoints were postoperative @entity354 , complications, and quality of life 12 months postoperatively. RESULTS: Forty @entity1 (9 male, 31 female) were randomized. @entity1 were well matched for baseline characteristics. At 3 months, the DeMeester score was higher after LMAH-C compared with LMAH-F (40.9    39.9 vs. 9.6    17; p  = 0.048). At 12 months, the @entity354 score was higher after LMAH-C compared with LMAH-F (1.9    1.2 vs. 1.1    0.4; p  = 0.020). In 53% of LMAH-C @entity1 and 17% of LMAH-F @entity1 , @entity86 was present (p  = 0.026). Values of @entity1282 (2.1    1.6 vs 1.9    1.4; p  = 0.737), gas bloating (2.6    1.4 vs 2.8    1.4; p  = 0.782), and quality of life (116.0    16.2 vs 115.9    15.8; p  =  0.992) were similar. Relevant @entity260 occurred in 4 (10%) @entity1 and did not differ between the groups. CONCLUSIONS: Laparoscopic repair of @entity357 should be combined with a fundoplication to avoid postoperative @entity354 and resulting @entity2910 . Fundoplication-related side effects do not appear to be clinically relevant. Multicenter randomized trials are required to confirm these findings.
