Degrees of New ICT Use Among Surgical Patients (NINASPA)

Degrees of New Information and Communication Technologies (ICT) Use Among Surgical Patients (NINASPA Study)

In recent years, the trend is for the patient to participate in their care. The development of new technologies together with the opportunities to exchange information, control one's own health and the possibility of communication between the team and the patient have increased. This is a prospective study trying to know the real use of ICT (information and communication technologies) among our surgical patients, its ability to use it and the differences in terms of gender, age or social range between others

Study Overview

• Status: Recruiting
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jose-M Ramirez; Phone Number: +34639776364; Email: jramirez@unizar.es
• Study Contact Backup: Name: Ana Victoria; Phone Number: 4920 +976556400; Email: anavickysp@hotmail.com

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Lozano Blesa
    • Contact: Jose-M Ramirez; Phone Number: +34639776364; Email: jramirez@unizar.es
    • Sub-Investigator: Ana Sanz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults in-hospital in our Department of Surgery patients, scheduled to any surgical procedure.

Description

Inclusion Criteria:

• Patients older than 18 years scheduled to surgery in our Department

Exclusion Criteria:

• Inability to read
• Inability to understand messages
• Emergency surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Use of ITC	Number of patients with access to Internet	6-12 months
Rate of Use Health applications	Number of patients with an Health app	6-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of acceptance of ITC	Degree of ITC use on a diary basis	6-12 months

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Principal Investigator: Jose-M Ramirez, Universidad de Zaragoza

Publications and helpful links

General Publications

• Lindberg B, Nilsson C, Zotterman D, Soderberg S, Skar L. Using Information and Communication Technology in Home Care for Communication between Patients, Family Members, and Healthcare Professionals: A Systematic Review. Int J Telemed Appl. 2013;2013:461829. doi: 10.1155/2013/461829. Epub 2013 Apr 10.
• Holthe T, Halvorsrud L, Karterud D, Hoel KA, Lund A. Usability and acceptability of technology for community-dwelling older adults with mild cognitive impairment and dementia: a systematic literature review. Clin Interv Aging. 2018 May 4;13:863-886. doi: 10.2147/CIA.S154717. eCollection 2018.
• Montroni I, Ugolini G, Saur NM, Spinelli A, Rostoft S, Millan M, Wolthuis A, Daniels IR, Hompes R, Penna M, Furst A, Papamichael D, Desai AM, Cascinu S, Gerard JP, Myint AS, Lemmens VEPP, Berho M, Lawler M, De Liguori Carino N, Potenti F, Nanni O, Altini M, Beets G, Rutten H, Winchester D, Wexner SD, Audisio RA. Personalized management of elderly patients with rectal cancer: Expert recommendations of the European Society of Surgical Oncology, European Society of Coloproctology, International Society of Geriatric Oncology, and American College of Surgeons Commission on Cancer. Eur J Surg Oncol. 2018 Nov;44(11):1685-1702. doi: 10.1016/j.ejso.2018.08.003. Epub 2018 Aug 15.
• Anderberg P, Skar L, Abrahamsson L, Berglund JS. Older People's Use and Nonuse of the Internet in Sweden. Int J Environ Res Public Health. 2020 Dec 4;17(23):9050. doi: 10.3390/ijerph17239050.
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Hernandez-Martinez FJ, Campi L, Quintana-Montesdeoca M feminineP, Jimenez-Diaz JF, Rodriguez-De-Vera BC, Parente A, Mata M feminineA, Pereira AM feminine, Fernandes A, Bras M, Pinto M feminineR, Parreira P, Basto ML, Rei AC, Monico LM, Sousa G, Morna C, Freitas O, Freitas G, Jardim A, Vasconcelos R, Horta LG, Rosa RS, Kranz LF, Nugem RC, Siqueira MS, Bordin R, Kniess R, Lacerda JT, Guedes J, Machado I, Almeida S, Zilhao A, Alves H, Ribeiro O, Amaral AP, Santos A, Monteiro J, Rocha M feminineC, Cruz R, Amaral AP, Lourenco M, Rocha M feminineC, Cruz R, Antunes S, Mendonca V, Andrade I, Osorio N, Valado A, Caseiro A, Gabriel A, Martins AC, Mendes F, Cabral L, Ferreira M, Goncalves A, Luz TD, Luz L, Martins R, Morgado A, Vale-Dias ML, Porta-Nova R, Fleig TC, Reuter EM, Froemming MB, Guerreiro SL, Carvalho LL, Guedelha D, Coelho P, Pereira A, Calha A, Cordeiro R, Goncalves A, Certo A, Galvao A, Mata M feminineA, Welter A, Pereira E, Ribeiro S, Kretzer M, Jimenez-Diaz JF, Jimenez-Rodriguez C, Hernandez-Martinez FJ, Rodriguez-De-Vera BDC, Marques-Rodrigues A, Coelho P, Bernardes T, Pereira A, Sousa P, Filho JG, Nazario N, Kretzer M, Amaral O, Garrido A, Veiga N, Nunes C, Pedro AR, Pereira C, Almeia A, Fernandes HM, Vasconcelos C, Sousa N, Reis VM, Monteiro MJ, Mendes R, Pinto IC, Pires T, Gama J, Preto V, Silva N, Magalhaes C, Martins M, Duarte M, Paul C, Martin I, Pinheiro AA, Xavier S, Azevedo J, Bento E, Marques C, Marques M, Macedo A, Pereira AT, Almeida JP, Almeida A, Alves J, Sousa N, Saavedra F, Mendes R, Maia AS, Oliveira MT, Sousa AR, Ferreira PP, Lopes LS, Santiago EC, Monteiro S, Jesus A, Colaco A, Carvalho A, Silva RP, Cruz A, Ferreira A, Marques C, Figueiredo JP, Paixao S, Ferreira A, Lopes C, Moreira F, Figueiredo JP, Ferreira A, Ribeiro D, Moreira F, Figueiredo JP, Paixao S, Fernandes T, Amado D, Leal J, Azevedo M, Ramalho S, Mangas C, Ribeiro J, Goncalves R, Nunes AF, Tuna AR, Martins CR, Forte HD, Costa C, Tenedorio JA, Santana P, Andrade JA, Pinto JL, Campofiorito C, Nunes S, Carmo A, Kaliniczenco A, Alves B, Mendes F, Jesus C, Fonseca F, Gehrke F, Albuquerque C, Batista R, Cunha M, Madureira A, Ribeiro O, Martins R, Madeira T, Peixoto-Placido C, Santos N, Santos O, Bergland A, Bye A, Lopes C, Alarcao V, Goulao B, Mendonca N, Nicola P, Clara JG, Gomes J, Querido A, Tomas C, Carvalho D, Cordeiro M, Rosa MC, Marques A, Brandao D, Ribeiro O, Araujo L, Paul C, Minghelli B, Richaud S, Mendes AL, Marta-Simoes J, Trindade IA, Ferreira C, Carvalho T, Cunha M, Pinto-Gouveia J, Fernandes MC, Rosa RS, Nugem RC, Kranz LF, Siqueira MS, Bordin R, Martins AC, Medeiros A, Pimentel R, Fernandes A, Mendonca C, Andrade I, Andrade S, Menezes RL, Bravo R, Miranda M, Ugartemendia L, Tena JM feminine, Perez-Caballero FL, Fuentes-Broto L, Rodriguez AB, Carmen B, Carneiro MA, Domingues JN, Paixao S, Figueiredo J, Nascimento VB, Jesus C, Mendes F, Gehrke F, Alves B, Azzalis L, Fonseca F, Martins AR, Nunes A, Jorge A, Veiga N, Amorim A, Silva A, Martinho L, Monteiro L, Silva R, Coelho C, Amaral O, Coelho I, Pereira C, Correia A, Rodrigues D, Marante N, Silva P, Carvalho S, Araujo AR, Ribeiro M, Coutinho P, Ventura S, Roque F, Calvo C, Reses M, Conde J, Ferreira A, Figueiredo J, Silva D, Seica L, Soares R, Mourao R, Kraus T, Abreu AC, Padilha JM, Alves JM, Sousa P, Oliveira M, Sousa J, Novais S, Mendes F, Pinto J, Cruz J, Marques A, Duarte H, Dixe MDA, Sousa P, Cruz I, Bastos F, Pereira F, Carvalho FL, Oliveira TT, Raposo VR, Rainho C, Ribeiro JC, Barroso I, Rodrigues V, Neves C, Oliveira TC, Oliveira B, Morais M feminineC, Baylina P, Rodrigues R, Azeredo Z, Vicente C, Dias H, Sim-Sim M, Parreira P, Salgueiro-Oliveira A, Castilho A, Melo R, Graveto J, Gomes J, Vaquinhas M, Carvalho C, Monico L, Brito N, Sarroeira C, Amendoeira J, Cunha F, Candido A, Fernandes P, Silva HR, Silva E, Barroso I, Lapa L, Antunes C, Goncalves A, Galvao A, Gomes M feminineJ, Escanciano SR, Freitas M, Parreira P, Maroco J, Fernandes AR, Cabral C, Alves S, Sousa P, Ferreira A, Principe F, Seppanen UM, Ferreira M, Carvalhais M, Silva M, Ferreira M, Silva J, Neves J, Costa D, Santos B, Duarte S, Marques S, Ramalho S, Mendes I, Louro C, Menino E, Dixe M, Dias SS, Cordeiro M, Tomas C, Querido A, Carvalho D, Gomes J, Valim FC, Costa JO, Bernardes LG, Prebianchi H, Rosa MC, Goncalves N, Martins MM, Kurcgant P, Vieira A, Bento S, Deodato S, Rabiais I, Reis L, Torres A, Soares S, Ferreira M, Graca P, Leitao C, Abreu R, Bellem F, Almeida A, Ribeiro-Varandas E, Tavares A, Frade JG, Henriques C, Menino E, Louro C, Jordao C, Neco S, Morais C, Ferreira P, Silva CR, Brito A, Silva A, Duarte H, Dixe MDA, Sousa P, Postolache G, Oliveira R, Moreira I, Pedro L, Vicente S, Domingos S, Postolache O, Silva D, Filho JG, Nazario N, Kretzer M, Schneider D, Marques FM, Parreira P, Carvalho C, Monico LM, Pinto C, Vicente S, Breda SJ, Gomes JH, Melo R, Parreira P, Salgueiro A, Graveto J, Vaquinhas M, Castilho A, Jesus A, Duarte N, Lopes JC, Nunes H, Cruz A, Salgueiro-Oliveira A, Parreira P, Basto ML, Braga LM, Ferreira A, Araujo B, Alves JM, Ferreira M, Carvalhais M, Silva M, Novais S, Sousa AS, Ferrito C, Ferreira PL, Rodrigues A, Ferreira M, Oliveira I, Ferreira M, Neves J, Costa D, Duarte S, Silva J, Santos B, Martins C, Macedo AP, Araujo O, Augusto C, Braga F, Gomes L, Silva MA, Rosario R, Pimenta L, Carreira D, Teles P, Barros T, Tomas C, Querido A, Carvalho D, Gomes J, Cordeiro M, Carvalho D, Querido A, Tomas C, Gomes J, Cordeiro M, Jacome C, Marques A, Capelas S, Hall A, Alves D, Lousada M, Loureiro M feminineH, Camarneiro A, Silva M, Mendes A, Pedreiro A, G.Silva A, Coelho ES, Melo F, Ribeiro F, Torres R, Costa R, Pinho T, Jacome C, Marques A, Cruz B, Seabra D, Carreiras D, Ventura M, Cruz X, Brooks D, Marques A, Pinto MR, Parreira P, Lima-Basto M, Neves M, Monico LM, Bizarro C, Cunha M, Galhardo A, Margarida C, Amorim AP, Silva E, Cruz S, Padilha JM, Valente J, Guerrero JT, Caballero FP, Santos RB, Gonzalez EP, Monago FM, Ugalde LU, Velez MM, Tena MJ, Guerrero JT, Bravo R, Perez-Caballero FL, Becerra IA, Agudelo M feminineE, Acedo G, Bajo R, Malheiro I, Gaspar F, Barros L, Furtado G, Uba-Chupel M, Marques M, Rama L, Braga M, Ferreira JP, Teixeira AM feminine, Cruz J, Barbosa T, Simoes A, Coelho L, Rodrigues A, Jimenez-Diaz JF, Martinez-Hernandez F, Rodriguez-De-Vera B, Ferreira P, Rodrigues A, Ramalho A, Petrica J, Mendes P, Serrano J, Santo I, Rosado A, Mendonca P, Freitas K, Ferreira D, Brito A, Fernandes R, Gomes S, Moreira F, Pinho C, Oliveira R, Oliveira AI, Mendonca P, Casimiro AP, Martins P, Silva I, Evangelista D, Leitao C, Velosa F, Carecho N, Coelho L, Menino E, Dixe A, Catarino H, Soares F, Gama E, Gordo C, Moreira E, Midoes C, Santos M, Machado S, Oliveira VP, Santos M, Querido A, Dixe A, Marques R, Charepe Z, Antunes A, Santos S, Rosa MC, Rosa MC, Marques SF, Minghelli B, CaroMinghelli E, Luis M feminineJ, Brandao T, Mendes P, Marinho D, Petrica J, Monteiro D, Paulo R, Serrano J, Santo I, Monteiro L, Ramalho F, Santos-Rocha R, Morgado S, Bento T, Sousa G, Freitas O, Silva I, Freitas G, Morna C, Vasconcelos R, Azevedo T, Soares S, Pisco J, Ferreira PP, Olszewer EO, Oliveira MT, Sousa AR, Maia AS, Oliveira ST, Santos E, Oliveira AI, Maia C, Moreira F, Santos J, Mendes MF, Oliveira RF, Pinho C, Barreira E, Pereira A, Vaz JA, Novo A, Silva LD, Maia B, Ferreira E, Pires F, Andrade R, Camarinha L, Silva LD, Maia B, Ferreira E, Pires F, Andrade R, Camarinha L, Cesar AF, Poco M, Ventura D, Loura R, Gomes P, Gomes C, Silva C, Melo E, Lindo J, Domingos J, Mendes Z, Poeta S, Carvalho T, Tomas C, Catarino H, Dixe M feminineA, Ramalho A, Rosado A, Mendes P, Paulo R, Garcia I, Petrica J, Rodrigues S, Meneses R, Afonso C, Faria L, Seixas A, Cordeiro M, Granjo P, Gomes JC, Souza NR, Furtado GE, Rocha SV, Silva P, Carvalho J, Morais MA, Santos S, Lebre P, Antunes A, Calha A, Xavier A, Cunha M, Pinto-Gouveia J, Alencar L, Cunha M, Madureira A, Cardoso I, Galhardo A, Daniel F, Rodrigues V, Luz L, 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R, Morais M feminineC, Fernandes PO, Santiago C, Figueiredo M feminineH, Basto ML, Guimaraes T, Coelho A, Graca A, Silva AM, Fonseca AR, Vale-Dias L, Minas B, Franco-Borges G, Simoes C, Santos S, Serra A, Matos M, Jesus L, Tavares AS, Almeida A, Leitao C, Varandas E, Abreu R, Bellem F, Trindade IA, Ferreira C, Pinto-Gouveia J, Marta-Simoes J, Amaral O, Miranda C, Guimaraes P, Goncalves R, Veiga N, Pereira C, Fleig TC, San-Martin EA, Goulart CL, Schneiders PB, Miranda NF, Carvalho LL, Silva AG, Topa J, Nogueira C, Neves S, Ventura R, Nazare C, Brandao D, Freitas A, Ribeiro O, Paul C, Merce C, Branco M, Almeida P, Nascimento D, Pereira J, Catela D, Rafael H, Reis AC, Mendes A, Valente AR, Lousada M, Sousa D, Baltazar AL, Loureiro M feminineH, Oliveira A, Aparicio J, Marques A, Marques A, Oliveira A, Neves J, Ayoub R, Sousa L, Marques-Vieira C, Severino S, Jose H, Cadorio I, Lousada M, Cunha M, Andrade D, Galhardo A, Couto M, Mendes F, Domingues C, Schukg S, Abrantes AM, Goncalves AC, Sales T, Teixo R, Silva R, Estrela J, Laranjo M, Casalta-Lopes J, Rocha C, Simoes PC, Sarmento-Ribeiro AB, Botelho M feminineF, Rosa MS, Fonseca V, Colaco D, Neves V, Jesus C, Hesse C, Rocha C, Osorio N, Valado A, Caseiro A, Gabriel A, Svensson L, Mendes F, Siba WA, Pereira C, Tomaz J, Carvalho T, Pinto-Gouveia J, Cunha M, Duarte D, Lopes NV, Fonseca-Pinto R, Duarte D, Lopes NV, Fonseca-Pinto R, Martins AC, Brandao P, Martins L, Cardoso M, Morais N, Cruz J, Alves N, Faria P, Mateus A, Morouco P, Alves N, Ferreira N, Mateus A, Faria P, Morouco P, Malheiro I, Gaspar F, Barros L, Parreira P, Cardoso A, Monico L, Carvalho C, Lopes A, Salgueiro-Oliveira A, Seixas A, Soares V, Dias T, Vardasca R, Gabriel J, Rodrigues S, Paredes H, Reis A, Marinho S, Filipe V, Lains J, Barroso J, Da Motta C, Carvalho CB, Pinto-Gouveia J, Peixoto E, Gomes AA, Costa V, Couto D, Marques DR, Leitao JA, Tavares J, Azevedo MH, Silva CF, Freitas J, Parreira P, Maroco J, Garcia-Gordillo MA, Collado-Mateo D, Chen G, 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Pinheiro AB, Aquino PS, Oliveira LL, Pinheiro PC, Sousa CR, Freitas VA, Silva TM, Lima AS, Aquino CQ, Andrade KV, Oliveira CA, Vidal EF, Ganho-Avila A, Moura-Ramos M, Goncalves O, Almeida J, Silva A, Brito I, Amado J, Rodrigo A, Santos S, Gomes F, Rosa MC, Marques SF, Luis S, Cavalheiro L, Ferreira P, Goncalves R, Lopes RS, Cavalheiro L, Ferreira P, Goncalves R, Fiorin BH, Santos MS, Oliveira ES, Moreira RL, Oliveira EA, Filho BL, Palmeira L, Garcia T, Pinto-Gouveia J, Cunha M, Cardoso S, Palmeira L, Cunha M, Pinto-Gouveia J, Marta-Simoes J, Mendes AL, Trindade IA, Oliveira S, Ferreira C, Mendes AL, Marta-Simoes J, Trindade IA, Ferreira C, Nave F, Campos M, Gaudencio I, Martins F, Ferreira L, Lopes N, Fonseca-Pinto R, Rodrigues R, Azeredo Z, Vicente C, Silva J, Sousa P, Marques R, Mendes I, Rodrigues R, Azeredo Z, Vicente C, Vardasca R, Marques AR, Seixas A, Carvalho R, Gabriel J, Ferreira PP, Oliveira MT, Sousa AR, Maia AS, Oliveira ST, Costa PO, Silva MM, Arreguy-Sena C, Alvarenga-Martins N, Pinto PF, Oliveira DC, Parreira PD, Gomes AT, Braga LM, Araujo O, Lage I, Cabrita J, Teixeira L, Marques R, Dixe M feminineA, Querido A, Sousa P, Silva S, Cordeiro E, Pimentel J, Ferro-Lebres V, Souza JA, Tavares M, Dixe M feminineA, Sousa P, Passadouro R, Peralta T, Ferreira C, Lourenco G, Serrano J, Petrica J, Paulo R, Honorio S, Mendes P, Simoes A, Carvalho L, Pereira A, Silva S, Sousa P, Padilha JM, Figueiredo D, Valente C, Marques A, Ribas P, Sousa J, Brandao F, Sousa C, Martins M, Sousa P, Marques R, Mendes F, Fernandes R, Martins E, Magalhaes C, Araujo P, Grande C, Mata M feminineA, Vieitez JG, Bianchini B, Nazario N, Filho JG, Kretzer M, Costa T, Almeida A, Baffour G, Almeida A, Costa T, Baffour G, Azeredo Z, Laranjeira C, Guerra M, Barbeiro AP, Ferreira R, Lopes S, Nunes L, Mendes A, Martins J, Schneider D, Kretzer M, Magajewski F, Soares C, Marques A, Batista M, Castuera RJ, Mesquita H, Faustino A, Santos J, Honorio S, Vizzotto BP, Frigo L, Pivetta HF, Sardo D, Martins C, Abreu W, Figueiredo M feminineC, Batista M, Jimenez-Castuera R, Petrica J, Serrano J, Honorio S, Paulo R, Mendes P, Sousa P, Marques R, Faustino A, Silveira P, Serrano J, Paulo R, Mendes P, Honorio S, Oliveira C, Bastos F, Cruz I, Rodriguez CK, Kretzer MR, Nazario NO, Cruz P, Vaz DC, Ruben RB, Avelelas F, Silva S, Campos M feminineJ, Almeida M, Goncalves L, Antunes L, Sardo P, Guedes J, Simoes J, Machado P, Melo E, Cardoso S, Santos O, Nunes C, Loureiro I, Santos F, Alves G, Soar C, Marsi TO, Silva E, Pedrosa D, Leca A, Silva D, Galvao A, Gomes M, Fernandes P, None A, Combadao J, Ramalhete C, Figueiredo P, Caeiro P, Fontana KC, Lacerda JT, Machado PO, Borges R, Barbosa F, Sa D, Brunhoso G, Aparicio G, Carvalho A, Garcia AP, Fernandes PO, Santos A, Veiga N, Bras C, Carvalho I, Batalha J, Gloria M, Bexiga F, Coelho I, Amaral O, Pereira C, Pinho C, Paraiso N, Oliveira AI, Lima CF, Dias AP, Silva P, Espada M, Marques M, Pereira A, Pereira AM feminine, Veiga-Branco M feminine, Pereira F, Ribeiro M, Lima V, Oliveira AI, Pinho C, Cruz G, Oliveira RF, Barreiros L, Moreira F, Camarneiro A, Loureiro M feminineH, Silva M, Duarte C, Jesus A, Cruz A, Mota M, Novais S, Nogueira P, Pereira A, Carneiro L, Joao PV, Lima TM, Salgueiro-Oliveira A, Vaquinhas M, Parreira P, Melo R, Graveto J, Castilho A, Gomes JH, Medina MS, Blanco VG, Santos O, Lopes E, Virgolino A, Dinis A, Ambrosio S, Almeida I, Marques T, Heitor M feminineJ, Garcia-Gordillo MA, Collado-Mateo D, Olivares PR, Parraca JA, Sala JA, Castilho A, Graveto J, Parreira P, Oliveira A, Gomes JH, Melo R, Vaquinhas M, Cheio M, Cruz A, Pereira OR, Pinto S, Oliveira A, Manso MC, Sousa C, Vinha AF, Machado M feminineM, Vieira M, Fernandes B, Tomas T, Quirino D, Desouzart G, Matos R, Bordini M, Mouroco P, Matos AR, Serapioni M, Guimaraes T, Fonseca V, Costa A, Ribeiro J, Lobato J, Martin IZ, Bjorklund A, Tavares AI, Ferreira P, Passadouro R, Morgado S, Tavares N, Valente J, Martins AC, Araujo P, Fernandes R, 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Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Surgery, Elderly patient, New technologies
• Other Study ID Numbers: UZaragoza-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No