Rajesh Aggarwal, MD, PhD, MA, FRCS, Joseph M Buchholz, BS, Iliana J Harrysson, MD, Kenric M Murayama, MD, FACS, Edward C Borrazzo, MD, Bruce A Chutter-Cressy, PA, John F Sweeney, MD, S Scott Davis, MD, Shirin Towfigh, MD, Rahul Gupta, MD, Daniel B Jones, MD, MS, FACS. Perelman School of Medicine at the University of Pennsylvania, Imperial College London, University of Vermont, Emory University, Cedars-Sinai Medical Center, Beth Israel Deaconess Medical Center.
INTRODUCTION: An important aspect of proper informed consent is the adequate and impartial transfer of information to the surgical patient prior to surgical treatment. Since 2007, the SAGES Educational Resources Committee has produced Patient Information Brochures (PIBs) for various laparoscopic procedures that can be used by surgeons to educate patients. We present preliminary results of a prospective, multi-institutional study investigating whether the use of the laparoscopic cholecystectomy (LC) or laparoscopic inguinal hernia (LH) SAGES PIBs resulted in a difference in patient understanding, anxiety, or satisfaction.
METHODS: Eleven centers of laparoscopic excellence across the USA agreed to collaborate on this trial. Of those eleven, four centers were able to successfully collect data for this study. The study was conducted in two arms at each center: the control arm and the PIB arm. In the control arm, 20 patients were recruited to participate (10 LC and 10 LH) and pre-operative informed consent was delivered as per current practice. Patients completed anxiety and satisfaction questionnaires both pre-operatively, and at their post-operative follow-up visits. In the PIB arm, 20 patients were recruited to participate and pre-op informed consent was delivered with inclusion of PIBs. As per the control arm, patients completed anxiety and satisfaction questionnaires pre and post-operatively.
RESULTS: A total of 43 control patients and 5 PIB patients participated in this study. 23 control patients underwent a LC and 20 underwent a LH procedure. Four PIB patients underwent LC whilst 1 underwent LH. Preoperatively, control LC patients rated high positive emotions (8.9±1.1 out of 12) and low negative emotions (4.7±0.8 out of 12). Similar results were noted for preoperative LH control patients (positive 9.5±0.9 out of 12, negative 4.4±0.7 out of 12) and preoperative LC PIB patients (positive 10.5±0.9 out of 12, negative 4.0±0.8 out 12). With regard to satisfaction with the consent process, all patients rated this extremely highly (LC control 1.5±0.6; LH control 1.4±0.5; LC PIB 1.8±1.0; scale 1 to 5, with 1 strongly content). Postoperatively, LC (2.3±1.4) and LH control patients (3.0±1.7) were less satisfied with the consent process than LC PIB patients (1.7±1.2). Finally, LC (2.2±1.3) and LH control patients (2.8±1.8) were less satisfied with the outcome of their surgery than LC PIB patients (1.5±0.7).
CONCLUSION: Patients in this study undergoing LC and LH procedures exhibited high positive and minimal negative emotions preoperatively, across all groups. Patients were satisfied with their consent preoperatively, though this level of satisfaction deteriorated post-operatively for the control patients, whilst remaining similar for PIB patients. Furthermore, overall contentment of surgical outcomes was superior for the patients exposed to PIBs. Though preliminary, the results of this study support the use of SAGES PIBs for the consent process of patients undergoing common, ambulatory laparoscopic procedures.
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