A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes - 19/06/15

Doi : 10.1016/j.jamcollsurg.2015.02.022

Juliane Bingener, MD, FACS ^a,^⁎ , Pam Skaran ^a, Andrea McConico ^a, Paul Novotny, MS ^b, Peter Wettstein, PhD ^c, David M. Sletten, MBA ^d, Myung Park, MD, FACS ^a, Philip Low, MD ^d, Jeff Sloan, PhD ^b
^a Department of Surgery, Mayo Clinic, Rochester, MN
^b Department of Health Sciences Research, Mayo Clinic, Rochester, MN
^c Department of Surgery and Immunology, Mayo Clinic, Rochester, MN
^d Department of Neurology, Mayo Clinic, Rochester, MN

^∗Correspondence address: Juliane Bingener, MD, FACS, Department of Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905.

Abstract

Background

The Institute of Medicine has included the comparison of minimally invasive surgical techniques in its research agenda. This study seeks to evaluate a model for the comparison of minimally invasive procedures using patient-reported outcomes.

Study Design

A double-blinded randomized controlled trial (NCT01489436) was conducted. Baseline data were obtained, standardized anesthesia was induced, and patients were randomized to single-port (SP) or 4-port (FP) laparoscopic cholecystectomy. Perioperative care was standardized. The outcomes were pain (Visual Analog Scale) on postoperative day 1 (primary) and quality of life (Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment), serum cytokines, and heart rate variability (secondary). Analysis was intention to treat. Using identical occlusive dressings, patients and the outcomes assessor remained blinded until postoperative day 2.

Results

Fifty-five patients were randomized to each arm. There was no difference in demographics. Visual Analog Scale pain score on postoperative day 1 was significantly different from baseline in each group (SP: 1.6 ± 1.9 to 4.2 ± 2.4 vs FP: 1.8 ± 2.3 to 4.2 ± 2.2), but not different from each other (p = 0.83). Patients in the FP arm reported significantly less fatigue on postoperative day 7 than patients in the SP group (3.1 ± 2.1 vs 4.2 ± 2.2; p = 0.009). Fewer patients in the FP group required postoperative oral narcotics before discharge (40% vs 60%; p = 0.056). Cytokines levels and heart rate variability were similar between arms. In patients followed for >1 year, no difference in umbilical hernia rates was noted.

Conclusions

Early postoperative quality of life data captured differences in fatigue, indicating improved recovery after FP within a controlled trial. Physiologic measures were similar, suggesting that the differences between SP and FP are minimal.

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Abbreviations and Acronyms : FP, HF, IL, LASA, LF, PRO, PROMIS, QOL, SP, T-score, VAS

Plan

Methods

Single-port cholecystectomy

Four-port laparoscopic cholecystectomy

Patient-Reported Outcomes Measures Information System and Linear Analog Self-Assessment

	Disclosure Information: Nothing to disclose.
	Disclosures outside the scope of this work: Dr Bingener is on the board of Titan Medical, Inc., and received grants from Nestle and Stryker Endoscopy and meeting expenses from Intuitive Surgical.
	Support: Research reported in this manuscript was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number K23DK93553, by Grant Number UL1 TR000135 from the National Center for Advancing Translational Sciences, and by Grant Number K08 GM093133-05 (MSP) from the National Institute of General Medical Sciences (NIGMS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.