Dataset Information

A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.

ABSTRACT: 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.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.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.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.

SUBMITTER: Bingener J

PROVIDER: S-EPMC4477204 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.

Bingener Juliane J Skaran Pam P McConico Andrea A Novotny Paul P Wettstein Peter P Sletten David M DM Park Myung M Low Philip P Sloan Jeff J

Journal of the American College of Surgeons 20150303 1

<h4>Background</h4>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.<h4>Study design</h4>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 ch ...[more]

PMID: 26095558

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Project description:BackgroundDuring the implementation of new interventions (i.e., surgical devices and technologies) in the operating room, surgical safety might be compromised. Current safety measures are insufficient in detecting safety hazards during this process. The aim of the study was to observe whether surgical teams are capable of measuring surgical safety, especially with regard to the introduction of new interventions.MethodsA Surgical Safety Questionnaire was developed that had to be filled out directly postoperative by three surgical team members. A potential safety concern was defined as at least one answer between (strongly) disagree and indifferent. The validity of the questionnaire was assessed by comparison with the results from video analysis. Two different observers annotated the presence and effect of surgical flow disturbances during 40 laparoscopic hysterectomies performed between November 2010 and April 2012.ResultsThe surgeon reported a potential safety concern in 16% (85/520 questions). With respect to the scrub nurse and anesthesiologist, this was both 9% (46/520). With respect to the preparation, functioning, and ease of use of the devices in 37.5-47.5% (15-19/40 procedures) a potential safety concern was reported by one or more team members. During procedures after which a potential safety concern was reported, surgical flow disturbances lasted a higher percentage of the procedure duration [9.3 ± 6.2 vs. 2.9 ± 3.7% (mean ± SD), p < .001]. After procedures during which a new instrument or device was used, more potential safety concerns were reported (51.2 vs. 23.1%, p < .001).ConclusionsPotential safety concerns were especially reported during procedures in which a relatively high percentage of the duration consisted of surgical flow disturbances and during procedures in which a new instrument or device was used. The Surgical Safety Questionnaire can act as a validated tool to evaluate and maintain surgical safety during minimally invasive procedures, especially during the introduction of a new intervention.

Project description:BACKGROUND:The creation of a single patient-reported outcome (PRO) platform validated across hip preservation, osteoarthritis (OA), and total hip arthroplasty (THA) populations may reduce barriers and streamline the routine collection of PROs in clinical practice. As such, the purpose of this study was to determine if augmenting the Hip disability and Osteoarthritis Outcome Score-Joint Replacement (HOOS, JR) with additional HOOS questions would result in a PRO platform that could be used across a wider spectrum of hip patient populations. HYPOTHESIS:The HOOS, JR would demonstrate a notable ceiling effect, but by augmenting the HOOS, JR with additional HOOS questions, a responsive PRO platform could be created. STUDY DESIGN:Cohort study (diagnosis); Level of evidence, 2. METHODS:Using preoperative and postoperative HOOS responses from a sample of 304 patients undergoing periacetabular osteotomy (PAO), additional items were identified to augment the HOOS, JR. The psychometric properties of a newly created PRO tool (HOOSglobal) were then compared with the HOOS, JR and other PRO instruments developed for patients with hip OA and/or undergoing THA. RESULTS:By augmenting the HOOS, JR with 2 additional questions, the HOOSglobal was more responsive than all other included PRO tools and had significantly fewer maximum postoperative scores than the HOOS, JR ( P < .0001), HOOS-Physical Function Short form ( P < .0001), Western Ontario and McMaster Universities Osteoarthritis Index ( P = .02), University of California, Los Angeles activity scale ( P = .0002), and modified Harris Hip Score ( P = .04). The postoperative HOOSglobal score threshold associated with patients achieving the patient acceptable symptom state (PASS) was 62.5. CONCLUSION:The HOOSglobal is a valid and responsive PRO tool after PAO and may potentially provide the orthopaedic community with a PRO platform to be used across hip-related subspecialties. For patients undergoing PAO, a postoperative HOOSglobal score ≥62.5 was associated with patients achieving the PASS.

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A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.

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A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes.

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