The introduction of laparoscopic surgery two decades ago revolutionized general surgery by minimizing abdominal wall incisions. Other new minimally invasive surgical techniques seek to further limit the trauma to the abdominal wall by reducing the number of or eliminating incisions on the abdominal wall. It is unclear whether these new techniques have any advantages over traditional laparoscopy. Validated, standardized comparison methods of one minimally invasive procedure with another are missing. For minimally invasive procedures, complication rates are low, and traditional, physician reported outcomes such as morbidity and survival are not useful. Biomarker investigations, such as serum cytokines, have been inconsistent. Comparisons with clinical outcomes are missing. Thus, there is a lack of valid tools to assess outcomes for benign disease in the minimally invasive surgery realm. In other fields, patient-reported outcome measures, such as pain and fatigue, have been demonstrated to be key vital signs in comparing treatment efficacy. Advances in standardization and psychometric integrity such as the NIH supported Patient-Reported Outcomes Measures Information System (PROMIS), have facilitated these comparisons. Patient-reported outcomes have outperformed physician-reported outcomes for predicting survival and toxicity from treatment in clinical trials. Additionally, patient-reported outcome changes appear to be correlated with biologic and physiologic system changes. We propose to apply patient-reported outcome measures for the efficient, consistent, and well-validated comparison of novel minimally invasive surgical procedures with standard of care procedures. A randomized blinded study of the new single-port and the standard four-port laparoscopic cholecystectomy (a procedure performed for more than 750,000 patients/year) will serve as the model to evaluate the comparative effectiveness of minimally invasive surgical approaches. The global health short form questionnaire, longitudinal analog self assessment and pain scales will serve as outcome measures. In addition, we will obtain data on perioperative biochemical and physiologic biomarkers such as serum levels of inflammatory cytokines and heart rate variability. This will serve as pilot data for future investigations into he relationship of biomarkers and patient reported outcomes in minimally invasive surgery for benign disease.

Public Health Relevance

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mentored Patient-Oriented Research Career Development Award (K23)
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Special Emphasis Panel (ZDK1-GRB-2 (M2))
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Podskalny, Judith M,
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Mayo Clinic, Rochester
United States
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Bingener, Juliane; Sloan, Jeff A; Novotny, Paul J et al. (2015) Perioperative patient-reported outcomes predict serious postoperative complications: a secondary analysis of the COST trial. J Gastrointest Surg 19:65-71; discussion 71
Bingener, Juliane; Thomsen, Kristine M; McConico, Andrea et al. (2015) Success of elective cholecystectomy treatment plans after emergency department visit. J Surg Res 193:95-101
Bingener, J; Ibrahim-zada, I (2014) Natural orifice transluminal endoscopic surgery for intra-abdominal emergency conditions. Br J Surg 101:e80-9
Bittner, R; Bingener-Casey, J; Dietz, U et al. (2014) Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)-part 1. Surg Endosc 28:2-29
Bittner, R; Bingener-Casey, J; Dietz, U et al. (2014) Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society [IEHS])-Part III. Surg Endosc 28:380-404
Bittner, R; Bingener-Casey, J; Dietz, U et al. (2014) Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society [IEHS])ýýýPart 2. Surg Endosc 28:353-79
Bingener, Juliane; Ghahfarokhi, Leili Shahgholi; Skaran, Pamela et al. (2013) Responsiveness of quality of life instruments for the comparison of minimally invasive cholecystectomy procedures. Surg Endosc 27:2446-53
Bingener, Juliane; Loomis, Erica A; Gostout, Christopher J et al. (2013) Feasibility of NOTES omental plug repair of perforated peptic ulcers: results from a clinical pilot trial. Surg Endosc 27:2201-8