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Processo decisionale riguardante un dispositivo medico: pre-analisi secondo PubMed

NOME DEL PRODOTTO: SPIDER (piattaforma chirurgica)

Nprodotto:*

8

Ncomplessivo:** 34

Sintassi PUBMED (con filtro su Clinical Trial):

*= “i-drive”

** = ("Electrosurgery/instrumentation"[mesh] OR "Equipment Design"[mesh]) AND (scissor* OR stapler*)

NOTE: Si è ritenuto di classificare questa situazione nella categoria “Prevalenza ergonomico-organizzativa” anziché

“Innovazione” perché i 34 studi di Ncomplessivo risultano frammentati su diversissime indicazioni di chirurgia. La realizzazione

di un report HTA su questo dispositivo potrebbe scontarsi con la mancanza di dati disponbili sui prodotti concorrenti.

Criteri per definire il risultato della pre-analisi orientativa:

-INNOVAZIONE: Il dispositivo richiesto ha meno di 3 studi (Nprodotto<3 ) ed appartiene ad una categoria di prodotti per i quali è disponibile un numero

elevato di studi clinici (Ncomplessivo >10)

-PREVALENZA CLINICO-EVIDENZIALE: Il dispositivo richiesto ha più di 3 studi ed appartiene ad una categoria di prodotti per i quali è disponibile un elevato

numero di studi clinici.

-PREVALENZA ERGONOMICO-ORGANIZZATIVA: Il dispositivo ha meno di 3 studi clinici ed appartiene ad una categoria di prodotti per i quali è disponibile

un esiguo numero di studi.

COME OTTENERE DA PUBMED I VALORI DI NPRODOTTO e di NCOMPLESSIVO::

1) Lanciare PUBMED sul nome del prodotto in questione ed annotare il numero di documenti avendolo “depurato” delle

citazioni spurie (es.: nome del prodotto che coincide con vocaboli “normali” o nomi di persone): si ottiene Nprodotto

2) Lanciare PUBMED sul nome prodotto del prodotto più usato per la stessa indicazione (e/o sullo specifico MESH term se disponibile)ed

annotare il numero di documenti avendolo “depurato” delle citazioni spurie (es. nome del prodotto che coincide con vocaboli “normali” o nomi di persona):

si ottiene NCOMPLESSIVO

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Nprodotto = 8 1: Kim SD, Landman J, Sung GT. Laparoendoscopic sin gle-site surgery with the second-generation single port instrument delivery e xtended reach surgical system in a porcine model. Korean J Urol. 2013 May;54(5):3 27-32. doi: 10.4111/kju.2013.54.5.327. Epub 2013 May 14. PubMed PMID: 23700499; PubMed Central PMCID: PMC3659227. 2: Bazzi WM, Stroup SP, Cohen SA, Sisul DM, Liss MA , Masterson JH, Kopp RP, Gudeman SR, Leeflang E, Palazzi KL, Ramamoorthy S, Kane CJ, Horgan S, Derweesh IH. Comparison of transrectal and transvaginal hybr id natural orifice transluminal endoscopic surgery partial nephrectomy in the porcine model. Urology. 2013 Jul;82(1):84-9. doi: 10.1016/j.urolog y.2013.03.007. Epub 2013 May 12. PubMed PMID: 23676357. 3: Knight J, Tunitsky-Britton E, Muffly T, Michener CM, Escobar PF. Single-port gynecologic surgery with a novel surgical platform. Surg Innov. 2012 Sep;19(3):316-22. doi: 10.1177/1553350611425506. Ep ub 2011 Nov 6. PubMed PMID: 22064489. 4: Leveillee RJ, Castle SM, Gorin MA, Salas N, Gorb atiy V. Initial experience with laparoendoscopic single-site simple nephrectom y using the TransEnterix SPIDER surgical system: assessing feasibility and s afety. J Endourol. 2011 Jun;25(6):923-5. doi: 10.1089/end.2010.0730. Epub 2 011 May 13. PubMed PMID: 21568757. 5: Salas N, Gorin MA, Gorbatiy V, Castle SM, Bird V G, Leveillee RJ. Laparoendoscopic single site nephrectomy with the S PIDER surgical system: engineering advancements tested in a porcine model. J Endourol. 2011 May;25(5):739-42. doi: 10.1089/end.2010.0608. Epub 2011 Mar 9. PubMed PMID: 21388244. 6: Villamizar N, Pryor AD. SPIDER and flexible lapa roscopy: the next frontier in abdominal surgery. Surg Technol Int. 2010 Oct;20:53 -8. PubMed PMID: 21082549. 7: Blackwell JN, Dean AC, Macleod IB, Sumerling MD, Finlayson ND. Laparoscopy and radioisotope imaging in the investigation of suspec ted liver disease. Dig Dis Sci. 1981 Jun;26(6):507-12. PubMed PMID: 6453707. 8: Pryor AD, Tushar JR, DiBernardo LR. Single-port cholecystectomy with the TransEnterix SPIDER: simple and safe. Surg Endosc. 2010 Apr;24(4):917-23. doi: 10.1007/s00464-009-0695-9. Epub 2009 Sep 16. PubMed PMID: 19760329; PubMed Central PMCID: PMC2846280. Ncomplessivo =34 1: Homma K, Otaki Y, Sugawara M, Kobayashi M. Effic acy of novel SB knife Jr examined in a multicenter study on colorectal endos copic submucosal dissection. Dig Endosc. 2012 May;24 Suppl 1:117-20. doi: 10.111 1/j.1443-1661.2012.01266.x. PubMed PMID: 22533765.

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2: Rahbari NN, Elbers H, Koch M, Bruckner T, Vogler P, Striebel F, Schemmer P, Mehrabi A, Büchler MW, Weitz J. Clamp-crushing vers us stapler hepatectomy for transection of the parenchyma in elective hepatic r esection (CRUNSH)--a randomized controlled trial (NCT01049607). BMC Surg . 2011 Sep 4;11:22. doi: 10.1186/1471-2482-11-22. PubMed PMID: 21888669; Pub Med Central PMCID: PMC3177759. 3: Gehrig T, Knebel P, Scheel V, Hinz U, Seiler CM, Müller-Stich BP, Büchler MW, Gutt CN. LigaSure Impact™ versus conventional disse ction technique in pylorus-preserving pancreatoduodenectomy in clinica l suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial. Trials. 2011 Jun 29;12:162. doi: 10.1186/174 5-6215-12-162. PubMed PMID: 21714879; PubMed Central PMCID: PMC3145578. 4: Calli C, Pinar E, Oncel S. Pharyngocutaneous fis tula after total laryngectomy: Less common with mechanical stapler closure. Ann Ot ol Rhinol Laryngol. 2011 May;120(5):339-44. PubMed PMID: 21675591. 5: Dauser B, Winkler T, Loncsar G, Herbst F. Compre ssion anastomosis revisited: prospective audit of short- and medium-term outcome s in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/ s00268-011-1135-2. PubMed PMID: 21541799. 6: Arroyo A, Pérez-Legaz J, Miranda E, Moya P, Ruiz -Tovar J, Lacueva FJ, Candela F, Calpena R. Long-term clinical results of double- pursestring stapled hemorrhoidopexy in a selected group of patients for the treatment of chronic hemorrhoids. Dis Colon Rectum. 2011 May;54(5):609-1 4. doi: 10.1007/DCR.0b013e3182092e51. PubMed PMID: 21471763 . 7: Ielpo B, Venditti D, Balassone V, Gioia A, Buono mo O, Petrella G. End-type stapled colostomy in emergency surgery. Surg Techno l Int. 2010 Oct;20:128-32. PubMed PMID: 21082557. 8: Attner P, Hemlin C, Söderman AC. Ligasure versus diathermy scissors tonsillectomy: A controlled randomized study. Acta Otolaryngol. 2010 Oct;130(10):1180-4. doi: 10.3109/00016481003702544. PubMed PMID: 20377504. 9: Cross KJ, Teo EH, Wong SL, Lambe JS, Rohde CH, G rant RT, Ascherman JA. The absorbable dermal staple device: a faster, more cos t-effective method for incisional closure. Plast Reconstr Surg. 2009 Jul;1 24(1):156-62. doi: 10.1097/PRS.0b013e3181a805c5. PubMed PMID: 19568054 . 10: Shang E, Hasenberg T, Magdeburg R, Keese M, Pos t S, Weiner R. First experiences with A circular stapled gastro-jejunost omy by a new transorally introducible stapler system in laparoscopic Roux-en -Y gastric bypass. Obes Surg. 2009 Feb;19(2):230-6. doi: 10.1007/s11695-008-9661- 1. Epub 2008 Aug 30. Retraction in: Obes Surg. 2012 Jul;22(7):1141. PubM ed PMID: 18758872. 11: Akahoshi K, Honda K, Akahane H, Akiba H, Matsui N, Motomura Y, Kubokawa M, Endo S, Higuchi N, Oya M. Endoscopic submucosal dis section by using a grasping-type scissors forceps: a preliminary clini cal study (with video). Gastrointest Endosc. 2008 Jun;67(7):1128-33. doi: 1 0.1016/j.gie.2007.12.007. Epub

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2008 Mar 19. PubMed PMID: 18355820. 12: Hasan H, Raitiola H, Chrapek W, Pukander J. Ran domized study comparing postoperative pain between coblation and bipolar sc issor tonsillectomy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):817-20. Epub 2007 Nov 23. PubMed PMID: 18034258. 13: Sivaslioglu AA, Unlubilgin E, Dölen I. The mult ifilament polypropylene tape erosion trouble: tape structure vs surgical techniq ue. Which one is the cause? Int Urogynecol J Pelvic Floor Dysfunct. 2008 Mar;19 (3):417-20. Epub 2007 Sep 18. PubMed PMID: 17876489. 14: Eitenmueller JP, Volckmann E. Clinical experien ce with bipolar multifunctional coagulation scissors in laparoscopi c surgery. Surg Endosc. 2008 Feb;22(2):421-5. PubMed PMID: 17623248. 15: Kobayashi M, Okamoto K, Okabyashi T, Akimori T, Namikawa T, Sakamoto J, Hanazaki K. Anti-reflux pouch-esophagostomy after t otal gastrectomy. Surg Technol Int. 2007;16:89-92. PubMed PMID: 17429774. 16: Varela Gutiérrez G, Castañeda Ortiz EM. [Hemorr hoidopexy with a PPH 03 circular stapler initial experience]. Rev Gastroent erol Mex. 2006 Jul-Sep;71(3):288-95. Spanish. PubMed PMID: 1714005 0. 17: Heyden Hv, Schäfer E, Jecker P, Gosepath J, Man n WJ. [Tonsillectomy technique: bipolar scissors vs raspatory: results o f a case control study in 138 patients]. HNO. 2007 Sep;55(9):684-9. German. PubMe d PMID: 17136555. 18: Pasic R, Abdelmonem A, Levine R. Comparison of cervical detachment using monopolar lap loop ligature and conventional method s in laparoscopic supracervical hysterectomy. JSLS. 2006 Apr-Jun;10(2 ):226-30. PubMed PMID: 16882425; PubMed Central PMCID: PMC3016112. 19: Ansel G, Yakubov S, Neilsen C, Allie D, Stoler R, Hall P, Fail P, Sanborn T, Caputo RP. Safety and efficacy of staple-mediated f emoral arteriotomy closure: results from a randomized multicenter study. Cathet er Cardiovasc Interv. 2006 Apr;67(4):546-53. PubMed PMID: 16538688. 20: Regadas FS, Regadas SM, Rodrigues LV, Misici R, Tramujas I, Barreto JB, Lins MA, Silva FR, Filho FS. New devices for stapled rec tal mucosectomy: a multicenter experience. Tech Coloproctol. 2005 Dec;9(3):243-6. Epub 2005 Nov 21. PubMed PMID: 16328119. 21: Bedrin L, Ginsburg G, Horowitz Z, Talmi YP. 25- year experience of using a linear stapler in laryngectomy. Head Neck. 2005 Dec ;27(12):1073-9. PubMed PMID: 16265656. 22: Nudelman I, Fuko V, Waserberg N, Niv Y, Rubin M , Szold A, Lelcuk S. Colonic anastomosis performed with a memory-shaped device. Am J Surg. 2005 Sep;190(3):434-8. PubMed PMID: 16105532.

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23: Yoshida J, Nagai K, Yokose T, Nishimura M, Kaki numa R, Ohmatsu H, Nishiwaki Y. Limited resection trial for pulmonary ground-gla ss opacity nodules: fifty-case experience. J Thorac Cardiovasc Surg. 2005 May;129( 5):991-6. PubMed PMID: 15867771. 24: Nudelman I, Fuko V, Rubin M, Lelcuk S. A nickel -titanium memory-shape device for colonic anastomosis in laparoscopic surgery. Su rg Endosc. 2004 Jul;18(7):1085-9. Epub 2004 May 27. PubMed PMID: 15 156389. 25: Heiss FW, Cimis RS Jr, MacMillan FP Jr. Biliary sphincter scissor for pre-cut access: preliminary experience. Gastrointest Endosc . 2002 May;55(6):719-22. PubMed PMID: 11979258. 26: Yamamoto H, Okada M, Kanehira A, Tachibana S, S aito H, Maniwa Y, Sakata K, Shibagaki F, Matsuda S, Kawamura M. Video-assisted blebectomy using a flexible scope and a bleb implement. Surg Today. 2000;30(3): 241-3. PubMed PMID: 10752776. 27: Matthews BD, Sing RF, DeLegge MH, Ponsky JL, He niford BT. Initial results with a stapled gastrojejunostomy for the laparoscop ic isolated roux-en-Y gastric bypass. Am J Surg. 2000 Jun;179(6):476-81. PubMed P MID: 11004334. 28: Sood S, Strachan DR. Re: Bipolar scissor tonsil lectomy. Clin Otolaryngol Allied Sci. 1999 Sep;24(5):465. PubMed PMID: 105429 34. 29: Haruguchi H, Nakagawa Y, Uchida Y, Sageshima J, Fuchinoue S, Agishi T. Clinical application of vascular closure staple cli ps for blood access surgery. ASAIO J. 1998 Sep-Oct;44(5):M562-4. PubMed PMID: 98 04495. 30: Dost P, Budach WD, Reide WD. [Single suture clo sure and surgical staplers in neck interventions after previous radiotherapy]. La ryngorhinootologie. 1997 Jun;76(6):364-7. German. PubMed PMID: 9333281. 31: Edelman DS, Unger SW. Bipolar versus monopolar cautery scissors for laparoscopic cholecystectomy: a randomized, prospec tive study. Surg Laparosc Endosc. 1995 Dec;5(6):459-62. PubMed PMID: 8611993. 32: Himel HN, Rodeheaver GT, Luterman A, Hargroder A, Bentrem DJ, Bill TJ, Morgan RF, Edlich RF. A new device for securing meshed spl it-thickness skin grafts. Scand J Plast Reconstr Surg Hand Surg. 1994 Dec;28( 4):299-303. PubMed PMID: 7899842. 33: Kiliaridis S, Egermark I, Thilander B. Anterior open bite treatment with magnets. Eur J Orthod. 1990 Nov;12(4):447-57. PubMe d PMID: 2086265. 34: Zederfeldt B, Jiborn H, Ekelund G. Sutureless c olonic anastomoses. Langenbecks Arch Chir. 1990;375(3):181-5. PubMed PM ID: 2192213.

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