BACKGROUND: Since the development of single-incision surgery, several retrospective studies have demonstrated its feasibility; however, randomized prospective trials are still lacking. We report a prospective randomized single-blinded trial with a cost analysis of single-incision (SI) to multi-incision (MI) laparoscopic cholecystectomy. STUDY DESIGN: After obtaining IRB approval, patients with chronic cholecystitis, acute cholecystitis, or biliary dyskinesia were offered participation in this multihospital, multisurgeon trial. Consenting patients were computer randomized into either a transumbilical SI or standard MI group; patient data were then entered into a prospective database. RESULTS: We report 79 patients that were prospectively enrolled and analyzed. Total hospital charges were found to be significantly different between SI and MI groups (MI $15,717 ± $14,231 vs SI $17,817 ± $5,358; p < 0.0001). Broken down further, the following subcharges were found to also be significant: operating room charges (MI $4,445 ± $1,078 vs SI $5,358 ± 893; p < 0.0001); medical/surgical supplies (MI $3,312 ± $6,526 vs SI $5,102 ± $1,529; p < 0.0001); and anesthesia costs (MI $579 ± $7,616 vs SI $820 ± $23,957; p < 0.0001). A validated survey (ie, Surgical Outcomes Measurement System) was used to evaluate various patient quality-of-life parameters at set visits after surgery; scores were statistically equivalent for fatigue, physical function, and satisfaction with results. No difference was found between visual analogue scale scores or inpatient and outpatient pain-medication use. CONCLUSIONS: We show SI surgery to have higher costs than MI surgery with equivalent quality-of-life scores, pain analogue scores, and pain-medication use.
RCT Entities:
BACKGROUND: Since the development of single-incision surgery, several retrospective studies have demonstrated its feasibility; however, randomized prospective trials are still lacking. We report a prospective randomized single-blinded trial with a cost analysis of single-incision (SI) to multi-incision (MI) laparoscopic cholecystectomy. STUDY DESIGN: After obtaining IRB approval, patients with chronic cholecystitis, acute cholecystitis, or biliary dyskinesia were offered participation in this multihospital, multisurgeon trial. Consenting patients were computer randomized into either a transumbilical SI or standard MI group; patient data were then entered into a prospective database. RESULTS: We report 79 patients that were prospectively enrolled and analyzed. Total hospital charges were found to be significantly different between SI and MI groups (MI $15,717 ± $14,231 vs SI $17,817 ± $5,358; p < 0.0001). Broken down further, the following subcharges were found to also be significant: operating room charges (MI $4,445 ± $1,078 vs SI $5,358 ± 893; p < 0.0001); medical/surgical supplies (MI $3,312 ± $6,526 vs SI $5,102 ± $1,529; p < 0.0001); and anesthesia costs (MI $579 ± $7,616 vs SI $820 ± $23,957; p < 0.0001). A validated survey (ie, Surgical Outcomes Measurement System) was used to evaluate various patient quality-of-life parameters at set visits after surgery; scores were statistically equivalent for fatigue, physical function, and satisfaction with results. No difference was found between visual analogue scale scores or inpatient and outpatientpain-medication use. CONCLUSIONS: We show SI surgery to have higher costs than MI surgery with equivalent quality-of-life scores, pain analogue scores, and pain-medication use.
Authors: Merritt Denham; Brandon Johnson; Michelle Leong; Kristine Kuchta; Eliza Conaty; Michael B Ujiki; Woody Denham; Stephen P Haggerty; Zeeshan Butt; JoAnn Carbray; Matt Gitelis; John G Linn Journal: Surg Endosc Date: 2019-01-09 Impact factor: 4.584