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

NOME DEL PRODOTTO: Suturatrice I-DRIVE

Nprodotto:*

3

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.

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 = 3 1: Sonoda T, Verdeja JC, Rivadeneira DE. Stapler ac cess and visibility in the deep pelvis: A comparative human cadaver study betw een a computerized right angle linear cutter versus a curved cutting stapler. Ann Surg Innov Res. 2011 Aug 27;5:7. doi: 10.1186/1750-1164-5-7. PubMed PMID: 21 871120; PubMed Central PMCID: PMC3189175. 2: Takata M, Watanabe G, Ohtake H, Ushijima T, Yama guchi S, Kikuchi Y, Yamamoto Y. Automatic aortic anastomosis with an innovative computer-controlled circular stapler for surgical treatment of aortic aneurysm. J Thorac Cardiovasc Surg. 2011 May;141(5):1265-9. doi: 10.1016/j.jtcvs.2010.05.048 . Epub 2010 Oct 13. PubMed PMID: 20947100. 3: Satoh Y, Matsui Y, Ogawa F, Amano H, Hara H, Nez u K, Iyoda A. Clinical report on a computer-controlled hand-actuated stapling sys tem for general lung surgery: the first application in Japan. Gen Thorac Cardiova sc Surg. 2009 Aug;57(8):402-5. doi: 10.1007/s11748-009-0407-3. Epub 2009 Sep 24. P ubMed PMID: 19779787. 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. 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:

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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 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

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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. 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.

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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.