A double-blinded randomized trial to compare the effectiveness of minimally invasive procedures using patient-reported outcomes

Juliane Bingener, Pam Skaran, Andrea McConico, Paul Novotny, Peter Wettstein, David M. Sletten, Myung (Michelle) S Park, Phillip Anson Low, Jeff A Sloan

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)111-121
Number of pages11
JournalJournal of the American College of Surgeons
Volume221
Issue number1
DOIs
StatePublished - Jul 1 2015

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Pain Measurement
Fatigue
Heart Rate
Occlusive Dressings
Quality of Life
Cytokines
Perioperative Care
Umbilical Hernia
National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division
Intention to Treat Analysis
Laparoscopic Cholecystectomy
Narcotics
Patient Reported Outcome Measures
Information Systems
Anesthesia
Randomized Controlled Trials
Demography
Serum
Research
Self-Assessment

ASJC Scopus subject areas

  • Surgery

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A double-blinded randomized trial to compare the effectiveness of minimally invasive procedures using patient-reported outcomes. / Bingener, Juliane; Skaran, Pam; McConico, Andrea; Novotny, Paul; Wettstein, Peter; Sletten, David M.; Park, Myung (Michelle) S; Low, Phillip Anson; Sloan, Jeff A.

In: Journal of the American College of Surgeons, Vol. 221, No. 1, 01.07.2015, p. 111-121.

Research output: Contribution to journalArticle

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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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