TITLE: Alternative Energy Devices for Adults Undergoing General Surgery: A Review of Clinical Effectiveness and Evidence-Based Guidelines

Transcription

1 TITLE: Alternative Energy Devices for Adults Undergoing General Surgery: A Review of Clinical Effectiveness and Evidence-Based Guidelines DATE: 11 December 2012 CONTEXT AND POLICY ISSUES Advances in surgical instrument technology have introduced energy-based devices that are able to simultaneously cut tissue and seal vessels, with the hope to overcome shortcomings that conventional hemostasis (e.g., electrocautery) can present, such as risk of tissue damage, difficult hemostasis and smoke production. 1,2 In order to avoid the shortcomings associated with conventional hemostasis, systems that use alternative energy such as bipolar radiofrequency (Coblation; ArthroCare Corp, Sunnivale, California), ultrasonic energy (Harmonic Scalpel; Ethicon Endo-Surgery Inc, Cincinnati, Ohio) and electrothermal bipolar vessel sealing systems (Ligasure; Valley-Lab, Boulder, Colorado) have been developed. These technologies involve controlled alteration of tissue and vessels through the application of electrical, ultrasonic or electrothermal energy. Radiofrequency generates a field of ionized sodium molecules and ablates and coagulates soft tissue. Ultrasonic devices transfer energy to the tissue leading to denaturation and coagulation of tissue protein. Electrothermal bipolar vessel sealing system delivers energy to denature tissue protein. 3 These technologies have been used in tissue ablation and blood coagulation for various surgical indications such as thyroidectomy, tonsillectomy, cholecystectomy, colorectal surgery, mastectomy and hemorrhoidectomy. 3 This report aims to review the clinical effectiveness of alternative energy devices for adults undergoing general surgery. The evidence-based guidelines for the use of alternative energy devices for adults undergoing general surgery will also be reviewed. RESEARCH QUESTIONS 1. What is the clinical effectiveness of alternative energy devices for use on adult patients undergoing general surgery? Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 2. What are the evidence-based guidelines for the use of alternative energy devices on patients undergoing general surgery in hospital? KEY FINDINGS There was some evidence that technologies using alternative energy sources such as ultrasound energy devices and electrothermal bipolar vessel sealing system can have potential advantages in comparison to conventional techniques in a variety of surgical procedures. Metaanalyses based on RCTs showed ultrasound energy provided better perioperative outcomes than conventional techniques for laparoscopic cholecystectomy and thyroid surgery; while electrothermal bipolar vessel sealing system was superior to conventional techniques for hemorrhoidectomy. No evidence-based guidelines for the use of alternative energy devices during surgery were identified. METHODS Literature Search Strategy A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2012, Issue 11), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI (Health Devices Gold), Canadian and major international health technology agencies, as well as a focused Internet search. Methodological filters were applied to limit retrieval to health technology assessments, systematic reviews, meta-analyses, randomized controlled trials, guidelines and comparative studies. The search was also limited to English language documents published between Jan 1, 2007 and Nov 15, Selection Criteria and Methods One reviewer screened the titles and abstracts of the retrieved publications and examined the full-text publications for the final article selection. Selection criteria are outlined in Table 1. Table 1: Selection Criteria Population Adults who are undergoing surgery Intervention Ultrasound, electrothermal energy or another frequency to cut tissue or vessels (e.g. Harmonic Scalpel or Sonsurg) Ultrasound, electrothermal energy or another frequency to coagulate tissue or vessels (e.g. Ligasure or Enseal) Comparator Conventional hemostatic techniques Outcomes Minimizing Comorbidities: vessel leaks, healing time, surgical time, anastomotic leaks Guidelines Study design Health technology assessments, systematic reviews, meta-analyses, guidelines. If no systematic reviews were identified, randomized controlled trials (RCTs) were selected for inclusion. Alternative Energy Devices for Surgery 2

3 Exclusion Criteria Articles were excluded if they did not meet the selection criteria in Table 1, if they were published prior to January 2007, if they were duplicate publications of the same study, or if they were referenced in a selected systematic review. Critical Appraisal of Individual Studies The quality of the included systematic reviews was assessed using the Amstar checklist. 4 Numerical scores were not calculated. Instead, the strengths and limitations of individual studies are summarized and presented. SUMMARY OF EVIDENCE Quantity of Available Evidence The literature search yielded 672 citations. No additional studies were identified by searching the grey literature. After screening of abstracts, 29 potentially relevant studies were selected for full-text review. Seven studies were included in the review. The PRISMA flowchart in Appendix 1 details the process of the study selection. Summary of Study Characteristics A detailed summary of the included studies is provided in Appendix 2. Study design This report included seven systematic reviews that compared the clinical effectiveness of electrothermal bipolar vessel sealing system or ultrasound energy devices to conventional techniques in which six conducted meta-analyses, 5-10 and one compared narratively the findings. 11 Population The comparisons were performed on patients undergoing colorectal surgery (397 patients), 5 laparoscopic cholecystectomy (1056 patients), 6 mastectomy (287 patients), 7 tonsillectomy (3139 patients), 8 thyroid surgery (1153 patients), 9 hemorrhoidectomy (1098 patients), 10 or abdominal surgical procedures (554 patients). 11 Interventions and comparators The meta-analyses compared electrothermal bipolar sealing system (Ligasure) to ultrasound energy devices, 5 Ligasure to ultrasound energy, radiofrequency ablation, and conventional techniques (cold steel and/or electrocautery), 8 Ligasure to stapled and conventional techniques, 10 ultrasound energy to conventional technique (electrocautery), 6,7 and ultrasound to other hemostatic methods combined (ligation and clip plus electrocauterization, Ligasure). 9 The narrative systematic review compared Ligasure to ultrasound energy and conventional surgery techniques (electrosurgical devices). 11 Alternative Energy Devices for Surgery 3

4 Outcomes Main reported clinical outcomes were operating time, 5,6,8-11 blood loss, 5-9,11 length of hospital stay, 6,11 pain, 6,8-10 and surgical complications. 6,7,9-11 Summary of Critical Appraisal All systematic reviews included in this review reported a priori design, and comprehensive literature search strategies Documentation of quality of included studies was not reported in four reviews. 5,9-11 Most systematic reviews performed meta-analyses with appropriate methods to combine findings The large variety of patients conditions across the included studies, together with diverse comparators included in the systematic reviews increased the generalizability of the findings. The number of included studies in each review was, however small, fewer than 15 studies in six out of seven reviews. Chi-squared values for pooled estimates showed statistical heterogeneity across trials in all meta-analyses Lack of assessment of the likelihood of publication bias is also a limitation in five reviews. 5,7,8,10,11 Details of the strengths and limitations of each individual study are summarized in Appendix 3. Summary of Findings: Main findings of included studies are summarized in detail in Appendix What is the clinical effectiveness of alternative energy devices for use on adult patients undergoing general surgery? Seven systematic reviews compared the clinical effectiveness of electrothermal bipolar vessel sealing systems, ultrasound energy devices or radiofrequency device to conventional techniques on various surgical conditions In general, the electrothermal bipolar vessel sealing system Ligasure and ultrasound energy harmonic scalpel were associated with shorter operating time and better perioperative clinical outcomes such as less blood loss, shorter length of hospital stay, and less postoperative pain than conventional techniques in a variety of surgical procedures. Radiofrequency device (Coblation) did not show benefits compared to conventional techniques in the conditions studied. Laparoscopic colorectal surgery Meta-analyses based on data from four controlled clinical trials on 397 patients undergoing laparoscopic colorectal surgery, compared electrothermal bipolar vessel sealing system to ultrasound energy. 5 Data from pooled estimates found that electrothermal bipolar vessel sealing system using Ligasure was associated with statistically significant shorter operative time (standardized mean difference [SMD] -0.72) and less intraoperative blood loss (SMD -0.51) than ultrasound energy devices. Alternative Energy Devices for Surgery 4

5 Laparoscopic cholecystectomy Meta-analyses based on data from eight RCTs on 1056 patients undergoing laparoscopic cholecystectomy, compared ultrasound energy devices to conventional techniques. 6 Data from pooled estimates found that ultrasound energy devices, compared to a conventional technique using electrocautery, was associated with statistically significant shorter operating time (18 min less), less intraoperative blood loss (41 ml less), shorter length of hospital stay (0.43 day less), less risk of having gallbladder perforation (69% risk reduction), and less pain at 24 hours after surgery (1.13 point less out of a 10-point scale). Operative conversion rates, bile leakage, intraabdominal collections and postoperative nausea at 24 hours were similar between the two methods. Mastectomy Meta-analyses based on data from six controlled clinical trials on 287 mastectomies compared ultrasound energy device to a conventional technique. 7 Data from pooled estimates found that ultrasound energy device using the harmonic scalpel was associated with statistically significant less intraoperative blood loss (SMD -1.04) compared to a conventional electrocautery technique. Operative time, wound complication, postoperative drainage and seroma development were similar between the two methods. No pooled outcome values were reported. Tonsillectomy Meta-analyses based on data from 33 RCTs on 3139 patients undergoing tonsillectomy, compared electrothermal bipolar vessel sealing system to conventional techniques, ultrasound energy to conventional techniques, and radiofrequency ablation to conventional techniques. 8 Electrothermal bipolar vessel sealing system using Ligasure, compared to conventional techniques using cold steel and/or electrocautery, was associated with statistically significant shorter operating time (4 min less), less perioperative blood loss (SMD -1.67), less risk for postoperative blood loss (72% risk reduction), and less pain at the first and seventh postoperative day (SMD and SMD -1.46, respectively). Ultrasound energy using a harmonic scalpel, compared to conventional techniques was associated with less perioperative blood loss (38 ml less). Operative time, postoperative blood loss and postoperative pain were similar between the two methods. Radiofrequency ablation technique using Coblation provided similar outcomes such as operative time, perioperative blood loss, postoperative blood loss and postoperative pain compared to conventional techniques. Thyroid surgery Meta-analyses based on data from 12 RCTs on 1153 patients undergoing thyroid surgery compared ultrasound energy to other hemostatic methods (suture ligation or clip ligation plus electrocautery, electrothermal bipolar vessel sealing system). 9 Alternative Energy Devices for Surgery 5

6 Data from pooled estimates found that ultrasound energy using a harmonic scalpel, compared with the combination of other surgical interventions (suture or clip ligation plus electrocautery, or electrothermal bipolar vessel sealing systems), was associated with statistically significant shorter operating time (23 min less), less intraoperative blood loss (20 ml less) and less postoperative pain (0.86 point less out of a 10-point visual analog scale). Volume of drainage fluid, complication rates and length of hospital stay were similar between ultrasound energy and the other methods combined. Hemorrhoid surgery Meta-analyses based on data from 11 RCTs on 1098 patients undergoing hemorrhoidectomy compared electrothermal bipolar vessel sealing system, stapled hemorrhoidectomy, and conventional hemorrhoidectomy. 10 Data from pooled estimates found that the Ligasure electrothermal bipolar vessel sealing system, compared to a conventional electrosurgical hemorrhoidectomy technique, was associated with statistically significant shorter operating time (12 min less), less postoperative pain (SMD -2.30), less risk for postoperative urinary retention (65% risk reduction), and shorter time to return to normal activity (5 days less). Abdominal surgeries A narrative systemic review of the literature included seven RCTs on 554 patients undergoing abdominal surgical procedures (laparoscopic colectomy, hepatic resection, laparoscopic adrenalectomy, laparoscopic hysterectomy, and laparoscopic salpingo-oophorectomy) compared electrothermal bipolar vessel sealing system, ultrasound energy, and mono- or bipolar electrosurgical devices. 11 A statistically significant difference was found in favour of Ligasure vessel sealing system in terms of blood loss, compared to ultrasound energy in one study on hepatic resection (210 ml vs 485 ml), and in one study on laparoscopic adrenalectomy (83 ml vs 210 ml). In one study on laparoscopic left side adrenalectomy, Ligasure was favored in terms of operating time, compared to ultrasound energy (52 min vs 68 min). There were no statistically significant differences in length of hospital stay and conversion rate to open surgery between different techniques in the included studies. 2. What are the evidence-based guidelines for the use of alternative energy devices on patients undergoing general surgery in hospital? There was no evidence found on the evidence-based guidelines for the use of alternative energy devices on patients undergoing general surgery in hospital. Limitations The limited number of studies in included systematic reviews and the heterogeneity across trials cautioned the interpretation of the results. The systematic reviews did not take into account the learning curve effect of clinicians who would perform better with time on the new devices. It is unclear whether statistically significant differences between the intervention and comparator Alternative Energy Devices for Surgery 6

7 groups reported reflect a true clinical significance. There was no study on cost-effectiveness found that would have facilitated the decision on the use of the new techniques. CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING There was some evidence that alternative energy devices can have potential advantages in comparison to conventional techniques in a variety of surgical procedures. Ultrasound energy (Harmonic Scalpel) provided shorter operating time, less blood loss and less postoperative pain in patients undergoing laparoscopic cholecystectomy and thyroid surgery, compared to conventional methods. Electrothermal bipolar vessel sealing system (Ligasure) was superior to conventional techniques with regard to operating time, postoperative pain, urinary retention and time to return to normal activity in patients undergoing hemorrhoids surgery, and shorter operating time, less blood loss and less postoperative pain in patients undergoing tonsillectomy. Radiofrequency device (Coblation) did not show benefits compared to conventional techniques in patients undergoing tonsillectomy. According to a Canadian RCT comparing clinical effectiveness and operative costs between Ligasure and conventional titanium clips and surgical ties in patients undergoing thyroid surgery, Ligasure did not provide shorter operating time but significantly increased the operative cost: Can$387 (SD $12) vs $74 (SD $28). 12 The utility of alternative energy devices should therefore be a balance between cost and effectiveness, especially when there are no apparent advantage in operative outcomes. The cost-effectiveness of alternative energy devices for surgery is unclear. PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: Alternative Energy Devices for Surgery 7

8 REFERENCES 1. Nduka CC, Super PA, Monson JR, Darzi AW. Cause and prevention of electrosurgical injuries in laparoscopy. J Am Coll Surg Aug;179(2): Grosskinsky CM, Hulka JF. Unipolar electrosurgery in operative laparoscopy. Capacitance as a potential source of injury. J Reprod Med Aug;40(8): McGuinness GB, McGeough JA, Gavin GP, O'Daly BJ. Surgical cutting and ablation by energy based devices: principles and applications [Internet]. International Conference on Advanced Manufacturing Systems and Technology; 2011 Jun 16-17; Mali Losinj, Croatia. [cited 2012 Nov 21]. Available from: 4. Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol [Internet] [cited 2012 Oct 17];7:10. Available from: 5. Lorenzo ND, Franceschilli L, Allaix ME, Asimakopoulos A, Sileri P, Gaspari AL. Radiofrequency versus ultrasonic energy in laparoscopic colorectal surgery: a metaanalysis of operative time and blood loss. Surg Endosc Oct;26(10): Xiong J, Altaf K, Huang W, Javed MA, Mukherjee R, Mai G, et al. A meta-analysis of randomized clinical trials that compared ultrasonic energy and monopolar electrosurgical energy in laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A Oct;22(8): Currie A, Chong K, Davies GL, Cummins RS. Ultrasonic dissection versus electrocautery in mastectomy for breast cancer - a meta-analysis. Eur J Surg Oncol Oct;38(10): Alexiou VG, Salazar-Salvia MS, Jervis PN, Falagas ME. Modern technology-assisted vs conventional tonsillectomy: a meta-analysis of randomized controlled trials. Arch Otolaryngol Head Neck Surg Jun;137(6): Ecker T, Carvalho AL, Choe JH, Walosek G, Preuss KJ. Hemostasis in thyroid surgery: harmonic scalpel versus other techniques--a meta-analysis. Otolaryngol Head Neck Surg Jul;143(1): Chen JS, You JF. Current status of surgical treatment for hemorrhoids--systematic review and meta-analysis. Chang Gung Med J [Internet] Sep [cited 2012 Nov 19];33(5): Available from: Janssen PF, Brolmann HA, Huirne JA. Effectiveness of electrothermal bipolar vesselsealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review. Surg Endosc Oct;26(10): Alternative Energy Devices for Surgery 8

9 12. Singh P, O'Connell D, Langille M, Dziegielewski P, Allegretto M, Harris J. LigaSure versus conventional hemostasis in thyroid surgery: prospective randomized controlled trial. J Otolaryngol Head Neck Surg Aug;39(4): Alternative Energy Devices for Surgery 9

10 Appendix 1: Selection of Publications 672 citations identified from electronic literature search and screened (abstracts) 0 potentially relevant reports retrieved from other sources (grey literature, hand search) 643 citations excluded 29 potentially relevant articles retrieved for scrutiny (full text) 22 reports excluded 7 reports included in review Alternative Energy Devices for Surgery 10

11 Appendix 2: Characteristics of Included Studies Table A1: Characteristics of Included Clinical Trials First Author, Year, Country, Study objectives Comparator(s) Included patients and study types Main clinical outcomes reported Meta-analysis Lorenzo, Italy Xiong, China Currie, UK Alexiou, England, Greece, US This study conducted a metaanalysis of controlled clinical trials comparing EBVS and UE in terms of operative time and intraoperative blood loss in laparoscopic colorectal surgery (p. 2917) This meta-analysis pooled the currently published randomized controlled trials comparing the safety and efficacy of ultrasonic energy and monopolar electrical energy in LC (p. 768) The aim of this systematic review was to compare the outcomes after mastectomy using novel ultrasonic dissection or standard electrocautery in published trials (p. 897) To systematically review evidence regarding modern technology assisted tonsillectomy pertaining to operative time, intraoperative and postoperative bleeding, postoperative pain, and other outcomes (p. 558) Electrothermal bipolar vessel sealing system (EBVS) and ultrasound energy (UE) device Electrocautery and ultrasound energy Electrocautery and ultrasound energy Ligasure Vessel Sealing System; ultrasound energy; radiofrequency ablation; conventional technique of cold steel and/or electrocautery Patients undergoing laparoscopic colorectal surgery Total: 4 studies; 397 patients Study type included in meta-analysis: controlled clinical trials Patients undergoing laparoscopic cholecystectomy Total: 8 studies; 1056 patients Study type included in meta-analysis: RCTs Patients undergoing mastectomy Total: 6 studies; 287 mastectomies Study type included in the meta-analysis: controlled clinical trials Patients undergoing tonsillectomy Total: 33 studies; 3139 patients Study type included in meta-analysis: RCTs Operative time; intraoperative blood loss Operative time; blood loss; hospital stay; gallbladder perforation; postoperative abdominal pain; operation conversion; bile leakage; intraabdominal collections; postoperative nausea Postoperative drainage; seroma development; intraoperative blood loss; operative time; complications Operative time; perioperative and postoperative bleeding; postoperative pain Alternative Energy Devices for Surgery 11

12 Table A1: Characteristics of Included Clinical Trials First Author, Year, Country, Study objectives Comparator(s) Included patients and study types Main clinical outcomes reported Ecker, Germany Chen, Taiwan Systematic review The objective is to systematically review the literature studying the harmonic scalpel versus other hemostatic techniques in thyroid surgical patients (p. 17) The objective of this study was to compare the effectiveness and safety of these two novel techniques with that of conventional hemorrhoidectomy (p. 488) Janssen, We conducted a systematic search The Netherlands for randomized controlled trials (RCTs) that compared the effectiveness and costs of vesselsealing devices with those of other electrothermal or ultrasonic devices in abdominal surgical procedures (p. 2892) RCTs: randomized controlled trials Ultrasound energy and other hemostatic methods (suture ligation or clip ligation plus electrocauterization, electrothermal bipolar vessel sealing system) Ligasure vessel sealing system, stapled hemorrhoidectomy and conventional hemorrhoidectomy Ligasure vessel sealing device; ultrasound energy and conventional surgery Patients undergoing thyroid surgery Total: 12 studies; 1153 patients Study type: RCTs Patients undergoing hemorrhoidectomy Total: 11 studies; 1098 patients Study type included in meta-analysis: RCTs Patients undergoing abdominal surgical procedures Total 7 studies; 554 patients Study type included in review: RCTs Operating time, blood loss, postoperative pain, lenghth of hospital stay, volume of fluid drainage, complications Operative time; postoperative pain; urinary retention; time to return to normal activity Operative time; blood loss; length of hospital stay Alternative Energy Devices for Surgery 12

13 Appendix 3: Summary of Critical Appraisal of Included Studies Table A2: Summary of Critical Appraisal of Included Studies First Author, Strengths Publication Year Meta-analysis Lorenzo, a priori design was provided independent data extractors comprehensive literature search status of publication was used as an inclusion criterion list of included studies provided characteristics of included studies provided methods to combine findings were appropriate conflict of interest was stated Xiong, a priori design was provided independent data extractors comprehensive literature search status of publication was used as an inclusion criterion list of included studies provided characteristics of included studies provided appropriate study design of included studies (RCTs) likelihood of publication bias was assessed quality of the included studies documented methods to combine findings were appropriate conflict of interest was stated Currie, a priori design was provided comprehensive literature search status of publication was used as an inclusion criterion list of included studies provided characteristics of included studies provided quality of the included studies documented methods to combine findings were appropriate conflict of interest was stated Alexiou, a priori design was provided comprehensive literature search status of publication was used as an inclusion criterion independent data extractors quality of the included studies documented list of included studies provided characteristics of included studies provided appropriate study design of included studies (RCTs) Limitations list of excluded studies not provided quality of the included studies not documented unsure if likelihood of publication bias was assessed list of excluded studies not provided reporting errors unsure if there were independent data extractors list of excluded studies not provided unsure if likelihood of publication bias was assessed list of excluded studies not provided unsure if likelihood of publication bias was assessed Alternative Energy Devices for Surgery 13

14 Ecker, Chen, Systematic review Janssen, methods to combine findings were appropriate conflict of interest was stated a priori design was provided comprehensive literature search status of publication was used as an inclusion criterion list of included studies provided characteristics of included studies provided appropriate study design of included studies (RCTs) methods to combine findings were appropriate likelihood of publication bias was assessed conflict of interest was stated a priori design was provided comprehensive literature search status of publication was used as an inclusion criterion list of included studies provided characteristics of included studies provided appropriate study design of included studies (RCTs) methods to combine findings were appropriate a priori design was provided comprehensive literature search status of publication was used as an inclusion criterion independent data extractors list of included studies provided characteristics of included studies provided appropriate study design of included studies (RCTs) conflict of interest was stated list of excluded studies not provided quality of the included studies not documented there were no independent data extractors reporting errors unsure if there were independent data extractors list of excluded studies not provided quality of the included studies not documented unsure if likelihood of publication bias was assessed conflict of interest was not stated there was no meta-analyses done quality of the included studies not documented list of excluded studies not provided unsure if likelihood of publication bias was assessed Alternative Energy Devices for Surgery 14

15 Appendix 4: Main Study Findings and Authors Conclusions Table A3: Main Study Findings and Authors Conclusions First Author, Main Study Findings Publication Year Research question 1 (clinical effectiveness of alternative energy devices) Meta-analysis Lorenzo, Electrothermal bipolar vessel sealing system (Ligasure) vs ultrasound energy (for colorectal surgery) Operating time (standardized difference) SMD: (95% CI, to to; P = 0.013) Authors Conclusions The metaanalysis indicated that EBVS is associated with a shorter operative time and less blood loss than UE in laparoscopic colorectal surgery (p. 2917) Xiong, Currie, Alexiou, Intraoperative blood loss (standardized difference) SMD: (95% CI, to ; P = 0.037) Ultrasound energy vs electrocautery (for laparoscopic cholecystectomy) Operative time (min) WMD: (95% CI, to ; P < ) Blood loss (ml) WMD: (95% CI, to ; P < ) Hospital stay (day) WMD: (95% CI, to -0.09; P = 0.01) Gallbladder perforation (risk) OR: 0.31 (95% CI, 0.22 to 0.44; P < ) Postoperative pain at 24 hours (score on 10-point visual analog scale) WMD: (95% CI, to -1.02; P < ) There was no statistically significant difference between the two methods for operative conversion, bile leakage, intraabdominal collections and postoperative nausea at 24 hours. Ultrasound energy (Harmonic Scalpel) vs electrocautery (for mastectomy) Intraoperative blood loss (standardized difference) WMD: (95% CI, to -0.08; P = 0.03) There was no statistically significant difference between the two methods for operative time, wound complication, postoperative drainage and seroma development. Electrothermal bipolar vessel sealing system (Ligasure), vs conventional technique (cold steel and/or electrocautery) (for tonsillectomy) Operative time (min) WMD: (95% CI, to -0.75; P = 0.02) Perioperative blood loss (standardized difference) SMD: (95% CI, to -0.53; P = 0.004) Postoperative blood loss (risk) Differences in mean operation time, mean blood loss, mean hospital stay, gallbladder perforation, and postoperative abdominal pain score at 24 hours were statistically significant between the two groups, in favor of the use of ultrasonic energy. However, there were no differences in operation conversion, bile leakage, intraabdominal collections, and postoperative nausea at 24 hours (p.768) Ultrasonic dissection and standard electrocautery appear to deliver similar results in the mastectomy setting (p. 897) For tonsillectomies, the Coblation and HS techniques do not provide any significant advantage compared with CS/EC. Synthesis of the limited and heterogeneous data regarding VSSs showed a significant benefit in all studied outcomes (p. 558) Alternative Energy Devices for Surgery 15

16 Table A3: Main Study Findings and Authors Conclusions First Author, Publication Year Main Study Findings OR: 0.28 (95% CI, 0.13 to 0.61; P = 0.001) Authors Conclusions Ecker, Chen, Pain on the first postoperative day (score on 10-point visual analog scale) SMD: (95% CI, to -0.39; P = 0.01) Pain on the seventh postoperative day (score on 10-point visual analog scale) SMD: (95% CI, to -0.57; P = 0.001) Ultrasound energy (Harmonic Scalpel) vs conventional technique (cold steel and/or electrocautery) (for tonsillectomy) Perioperative blood loss (ml) WMD: (95% CI, to ; P < 0.001) There was no statistically significant difference between the methods for operative time, postoperative blood loss, postoperative pain. Radiofrequency abalation (Coblation) vs conventional technique (cold steel and/or electrocautery) (for tonsillectomy) There was no statistically significant difference between the methods for operative time, perioperative blood loss, postoperative blood loss and postoperative pain. Ultrasound energy (Harmonic Scalpel) vs other hemostatic methods (suture ligation/clip ligation plus electrocauterization, electrothermal bipolar vessel sealing system) (for thyroid surgery) Operating time (min) WMD: (95% CI, to ; P < ) Blood loss (ml) WMD: (95% CI, to ; P < ) Postoperative pain (score on 10-point visual analog scale) WMD: (95% CI, to -0.13; P = 0.02) There was no statistically significant difference between the methods for volume of drainage fluid, complication rate and hospital stay. Electrothermal bipolar vessel sealing system (Ligasure) vs conventional electrosurgery (for hemorrhoidectomy) Operating time (min) WMD: (95% CI, to ; P < ) Postoperative pain (score on 10-point visual analog scale) SMD: (95% CI, to -2.18) Postoperative urinary retention (risk) OR: 0.35 (95% CI, 0.16 to 0.77) There is clear evidence that using the harmonic scalpel for hemostasis in thyroid surgery significantly reduces operating time and blood loss and that it is not associated with an increase in volume of drainage fluid, complication rate, or hospital stay (p. 17) Both PPH and Ligasure hemorrhoidectomy were superior to conventional hemorrhoidectomy with regard to operation time, early postoperative pain, urinary retention, and time to return to normal activity (p. 488) Alternative Energy Devices for Surgery 16

17 Table A3: Main Study Findings and Authors Conclusions First Author, Publication Year Main Study Findings Time to return to normal activity (days) WMD: (95% CI, to -4.75) Systematic review Janssen, Electrothermal bipolar vessel sealing system (Ligasure) vs ultrasound energy, conventional electrosurgical method (mono or bipolar electrothermal devices) (for abdominal surgeries) Ligasure was favored in terms of less blood loss, compared to ultrasound energy, in one study on laparoscopic adrenalectomy (83 ml vs 210 ml; P < 0.5)), and in one study on hepatic resection (210 ml vs 485 ml ; P < 0.05). No differences in blood loss observed in the remaining studies on laparoscopic colectomy, laparoscopic hysterectomy and laparoscopic salpingo-oophorectomy. Authors Conclusions Vessel-sealing devices may be considered safe and their use may reduce costs due to reduced blood loss and shorter operating time in some abdominal surgical procedures compared to mono- or bipolar electrothermal devices (p 2892) Ligasure was favored in terms of operating time, compared to ultrasound energy, in one study on laparoscopic left side adrenalectomy (52 min vs 69 min, P = 0.02). No differences in operating time observed in the remaining studies. Length of hospital stay, conversion rate to open surgery: no statistically significant differences in all studies. Research question 2 (evidence-based guidelines for alternative energy devices) No studies identified for this research question CS/EC: cold steel/electrocautery; EBVS: electrothermal bipolar vessel sealing (Ligasure); HS: Harmonic Scalpel; OR: odds ratio; SMD: standardized mean difference; UE: ultrasound energy; VSS: vessel sealing system; WMD: weighted mean difference Alternative Energy Devices for Surgery 17