Page 52 - Prevention and Treatment of Incisional Hernia- New Techniques and Materials

Chapter 3
incisional hernia as a binary endpoint if it took place up to 15 months after randomisation, with cross-table and logistic regression as the natural analyses, rather than Kaplan-Meier and Cox-regression analyses. Statistical comparison of quality of life between patient groups (small vs large bites technique and with or without incisional hernia during follow-up) was done by multilevel analysis (linear mixed-e ects model with random e ect for each patient). Time, randomisation (small vs large bites), and the interaction between time and randomisation were main e ects, with adjustment for age and sex. Analysis was by intention to treat. We did statistical analysis with SPSS (version 20.0) and R statistical software (version 3.1.0).
This trial is registered with Clinicaltrials.gov, number NCT01132209, and Nederlands Trial Register, number NTR2052.
Role of the funding source
The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all the data in the study and had nal responsibility for the decision to submit for publication.
Results
The gure shows the trial pro le. Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=248) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) completed follow-up and were included in the primary outcome analysis ( gure). Baseline characteristics were similar between groups, except that slightly more patients with COPD were included in the small bites group (table 1). Most surgical procedures were for gastrointestinal oncological diseases and consisted of opening or partial resection of the gastrointestinal tract (table 1).
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