Patient-reported Outcomes After Single-incision Laparoscopic Cholecystectomy vs Traditional Laparoscopic Cholecystectomy: A Randomized, Prospective Trial

Matthew Sappington, MD, B Todd Moore, MD, Daniel J Margolin, MD, G Brent Sorensen, MD, Fengming Tang, MS, Kimberly M Brown, MD. Saint Luke’s Hospital of Kansas City, Department of Surgery, University of Missouri-Kansas City

 

Introduction: Single incision laparoscopic cholecystectomy (SILC) is a newer approach that has been shown to be a safe alternative to traditional laparoscopic cholecystectomy (TLC) in retrospective and small prospective studies. We do not yet have accurate data to inform patients about what specific benefits may be expected with SILC compared to TLC. As the demand for single-incision surgery may be driven by patient perceptions of benefits, we designed a prospective randomized study using patient-reported outcomes as our endpoints.

Methods: We performed a randomized, controlled trial comparing patient reported outcomes following SILC or TLC. After obtaining informed consent, patients scheduled to undergo elective cholecystectomy were randomized to SILC or TLC, stratifying for surgeon, diagnosis, body mass index (BMI), and prior abdominal surgery. Patients were blinded to the procedure by using uniform dressings that were maintained for 48 hours after surgery. Preoperative characteristics and perioperative data were recorded. Pain scores were recorded in recovery and at 48 hours. Satisfaction with wound appearance and perceptions of pain at 2 and 4 weeks were reported by patients on a 5-point Likert scale. We used the validated Gastrointestinal Quality of Life Index (GIQLI) survey preoperatively and at 2 and 4 weeks postoperatively to assess recovery. Procedural and total hospital cost per case were abstracted from hospital billing systems

Results: We enrolled 90 patients and randomized 70 to date. Patients left study because of patient desire for one procedure (12), no surgery was performed (4) or surgeon determined patient was not SILC candidate (4). Complete follow-up data are available for 32 SILC and 27 TLC patients. Mean age was 44 years (+/- 14), 83% were Caucasian, and 78% were female, with no difference between groups. Operative time was longer for SILC (60.1 +/- 22.7 minutes vs 49.4 +/- 13.6 minutes, p=0.036), but mean LOS was similar (6.8 +/- 4.8 hours SILC vs 5.9 +/- 4.7 hours TLC, p=0.47). Operating room cost ($852 +/-$182 SILC vs $879 +/- $153 TLC, p=0.56) and encounter cost ($3035 +/- $1000 SILC vs $3225 +/- $1183 TLC, p=0.541) were similar. GIQLI scores were not significantly different preoperatively, or at 2 or 4 weeks. Patients reported a mean of 9.3 +/-7.2 days from surgery to complete resumption of normal activities with SILC, and 8.7 +/-4.4 days with TLC (p=0.68). Patients reported higher satisfaction with wound appearance at 2 weeks with SILC, but there was no difference at 4 weeks. There were no differences in pain scores in recovery or at 2 or 4 weeks.

Conclusions: SILC is a longer operation, but can be done at the same cost as TLC. Recovery is not faster with SILC, and pain scores are not significantly different. There may be an improvement in patient satisfaction with wound appearance at 2 weeks. While demand for single-incision surgery may be driven by patient perceptions of benefit, further study is needed to accurately inform patients as to what benefit they may derive from SILC over TLC. Both procedures are valid approaches to cholecystectomy.
 


Session Number: SS23 – Plenary II
Program Number: S130

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