title: Insights into surgical trials: methodological challenges and solutions.
abstract: BACKGROUND
  Novel surgical methods and procedures used to be introduced by experts and were established depending on the corresponding success that was noted. Surgical trials representing evidence level 1b were and still are called into question for different reasons. Prospective randomized controlled trials comparing various surgical strategies that were conducted over the past 11 years in the clinical trial unit in the department of general, visceral, and transplantation surgery of the University of Heidelberg pointed out problems as well as possible solutions for surgical trials' characteristics.
  
  
  OBJECTIVE
  When planning a study within a department of surgery, several aspects have to be considered. The article aims at outlining pitfalls that have to be dealt with as well as possible solutions by outlining experiences within several conducted trials.
  
  
  CONCLUSIONS
  The compilation of solutions announcing the challenges of surgical studies shows that valid high-quality trials are feasible.
authors.affiliation: Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany.
authors.forename: Colette
authors.initials: C
authors.lastname: Doerr-Harim
authors.forename: Thomas
authors.initials: T
authors.lastname: Bruckner
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Phillip
authors.initials: P
authors.lastname: Knebel
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D017063:Outcome Assessment, Health Care; D012107:Research Design; D013514:Surgical Procedures, Operative