Randomized controlled trial of 2.5-cm versus 3.5-cm mesial temporal resection in XXXX --Part 1: intent-to-treat analysis.

@entity1 @entity410 @entity1315 @entity302
BACKGROUND: Only one prospective randomized study on the extent of mesial resection in surgery for @entity1315 ( @entity1315 ) exists. This randomized controlled trial (RCT) examines whether 3.5-cm mesial resection is leading to a better @entity410 outcome than a 2.5-cm resection. METHODS: Three @entity302 surgery centers using similar MRI protocols, neuropsychological tests, and resection types for @entity1315 surgery included 207 @entity1 in a RCT with pre- and postoperative volumetrics. One hundred and four @entity1 were randomized into a 2.5-cm resection group and 103 @entity1 into a 3.5-cm resection group, i.e., an intended minimum resection length of 25 versus 35 mm for the hippocampus and parahippocampus. Primary outcome measure was @entity410 freedom Engel class I throughout the first year. The study was powered to detect a 20% difference in class I outcome. @entity410 outcome was available for 207 @entity1 , complete volumetric results for 179 @entity1 . Outcome analysis was restricted to control of successful randomization and an intent-to-treat analysis of @entity410 outcome. RESULTS: The mean true resection volumes were significantly different for the 2.5-cm and 3.5-cm resection groups; thus, the randomization was successful. Median resection volume in the 2.5-cm group was 72.86% of initial volume and 83.44% in the 3.5-cm group. At 1 year, @entity410 outcome Engel class I was 74% in the 2.5-cm and 72.8% in the 3.5-cm resection group. CONCLUSIONS: The primary intent-to-treat analysis did not show a different @entity410 freedom rate for the more posteriorly reaching 3.5-cm resection group. It appears possible that not maximal volume resection but adequate volume resection leads to good @entity410 freedom.
