Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial
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Single-incision laparoscopic cholecystectomy evolved from the traditional multiport laparoscopic technique. Prior trials have demonstrated improved cosmesis with the single-incision technique. Robotic single-site surgery minimizes the technical difficulties associated with laparoscopic single-incision approach. This is the first prospective, randomized, controlled study comparing robotic single-site cholecystectomy (RSSC) and multiport laparoscopic cholecystectomy (MPLC) in terms of cosmesis and patient satisfaction.
Patients with symptomatic benign gallbladder disease were randomized to RSSC or MPLC. Data included perioperative variables such as operative time, conversion and complications and cosmesis satisfaction, body image perception, quality of life using validated questionnaires, at postoperative visits of 2, 6 weeks and 3 months.
One hundred thirty-six patients were randomized to RSSC (N = 83) and MPLC (N = 53) at 8 institutions. Both cohorts were dominated by higher enrollment of females (RSSC = 78%, MPLC = 92%). The RSSC and MPLC cohorts were otherwise statistically matched. Operative time was longer for RSSC (61 min vs. 44 min, P < 0.0001). There were no differences in complication rates. RSSC demonstrated a significant superiority in cosmesis satisfaction and body image perception (P value < 0.05 at every follow-up). There was no statistically significant difference in patient-reported quality of life. Multivariate analysis of female patients demonstrated significantly higher preference for RSSC over MPLC in cosmesis satisfaction and body image perception with no difference seen in overall quality of life.
Results from this trial show that RSSC is associated with improved cosmesis satisfaction and body image perception without a difference in observed complication rate. The uncompromised safety and the improved cosmesis satisfaction and body image perception provided by RSSC for female patients support consideration of the robotic single-site approach.
ClinicalTrials.gov identifier NCT01932216.
KeywordsLaparoscopy Robotic-assisted surgery Single-port cholecystectomy Multiport cholecystectomy Cosmesis Quality of life
The authors would like to thank the following independent contributors: Mimi Wainwright (Wainwright Medical Communications, Los Gatos, CA USA) for editorial support and Vijaya Bharathi Lingala, Ph.D. (Institute of Clinical Outcomes Research and Education, Woodside CA and Department of Cardiothoracic Surgery, Stanford University, Palo Alto, CA USA) for her contribution toward the statistical study design and study data analysis.
This study was sponsored and funded by Intuitive Surgical, Inc., Sunnyvale, CA, USA in association with the identified study investigators under a cooperative clinical trial agreement. The authors had full control of the study execution, analysis, and development of the manuscript.
Compliance with ethical standards
All authors received research study support from Intuitive Surgical, statistical analysis from the Institute of Clinical Outcomes Research and Education, and editorial support from Wainwright Medical Communications. Dr. Kudsi has received honoraria and research study support outside the scope of this work. Dr. Kaza is a consultant for Intuitive. Dr. Dickens is a consultant for Intuitive and has received grants from Intuitive as well as speakers bureau fees and fees to develop educational presentations. Dr. Martin receives fees as a proctor for Intuitive. Ms. Mehendale is an employee of Intuitive. Dr. Gonzalez receives consultancy fees from Ethicon Endo Surgery, Mallinkrodt Pharmaceuticals, and Minimally Invasive Devices outside the scope of this work. Omar Yusef Kudsi, Andres Castellanos, Srinivas Kaza, Justin McCarty, Eugene Dickens, David Martin, Frederick M. Tiesenga, Konstantinos Konstantinidis, Petros Hirides, Shilpa Mehendale, and Anthony Gonzalez have no other conflicts of interest or financial ties to disclose.
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