Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older: a randomised controlled trial
Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this...
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| Veröffentlicht in: | EClinicalMedicine 2023-10, Vol.64, p.102207, Article 102207 |
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| creator | Van den Dop, L. Matthijs Van Egmond, Sarah Heijne, Jort Heijne, Jort van Rosmalen, Joost de Goede, Barry Wijsmuller, Arthur R. Kleinrensink, Gert-Jan Tanis, Pieter J. Jeekel, Johannes Lange, Johan F. Lange, Johan F. van den Dop, Matthijs van Egmond, Sarah van Rosmalen, Joost Tanis, Pieter de Goede, Barry Kleinrensink, Gert-Jan Jeekel, Johannes Van Ramshorst, Gabrielle H. Klitsie, Pieter J. van Kempen, Bob J.H. Hunink, Myriam G.M. Hop, Wim C. Halm, Jens A. Burger, Pim J.W.A. Brandt, Alexandra Franssen, Gaston J.H. Oomen, Jan Wijsmuller, Arthur R. Roumen, Rudi M.H. Schelting, Marc R.M. Boelens, Oliver Susa, Denis Verhagen, Tim Rath, Hiltjo J. Lont, Harold E. Mannaerts, Guido H. de Haan, Jeroen Mastboom, Walter Swank, Dingeman J. Schmitz, Roderick F. Zijsling, Bonnie Bouvy, Nicole D. Schreinemacher, Marc H.F. van Barneveld, Kevin Ploeg, Arianne J. Contant, C. van der Harst, Erwin de Rooij, Peter D. Deelman, Tara van Hout, Naomi Stasssen, Laurents P.S. Go, Peter M.N.Y.H. Roumen, R. Simons, Maarten P. Schreurs, Hermien W.H. Keyzer-Dekker, Claudia M.G. Takkenberg, Marijn Ugahary, Franz Liqui Lung, Paul F. de Roos, Marnix A.J. Ong, Paul K.H. Wijffels, Rob T.M. Vierhout, Bas P. Donse, Irene F. Pierik, E.G.J.M. Buijk, Steven Dawson, Imro Kloppenberg, Frank van den Broek, Rob W.F.R. van Geloven, A. Postema, Roelf R. Cate, W. Ten Rakic, Serdjan Schoenmaeckers, Ernst J.P. Plaisier, Peter W. Berendes, Thomas Oostenbroek, Rob J. Poyck, Paul P.C. van Geffen, Erwin H.J.A.A. Ruurda, Jelle Smulders, Frans J.F. Pierik, Robert E.G.J.M. Miserez, Marc Haers, Paul Mulier, Karel |
| description | Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.
In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629.
Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%).
During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.
The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding. |
| doi_str_mv | 10.1016/j.eclinm.2023.102207 |
| format | Article |
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Matthijs ; Van Egmond, Sarah ; Heijne, Jort ; Heijne, Jort ; van Rosmalen, Joost ; de Goede, Barry ; Wijsmuller, Arthur R. ; Kleinrensink, Gert-Jan ; Tanis, Pieter J. ; Jeekel, Johannes ; Lange, Johan F. ; Lange, Johan F. ; van den Dop, Matthijs ; van Egmond, Sarah ; van Rosmalen, Joost ; Tanis, Pieter ; de Goede, Barry ; Kleinrensink, Gert-Jan ; Jeekel, Johannes ; Van Ramshorst, Gabrielle H. ; Klitsie, Pieter J. ; van Kempen, Bob J.H. ; Hunink, Myriam G.M. ; Hop, Wim C. ; Halm, Jens A. ; Burger, Pim J.W.A. ; Brandt, Alexandra ; Franssen, Gaston J.H. ; Oomen, Jan ; Wijsmuller, Arthur R. ; Roumen, Rudi M.H. ; Schelting, Marc R.M. ; Boelens, Oliver ; Susa, Denis ; Verhagen, Tim ; Rath, Hiltjo J. ; Lont, Harold E. ; Mannaerts, Guido H. ; de Haan, Jeroen ; Mastboom, Walter ; Swank, Dingeman J. ; Schmitz, Roderick F. ; Zijsling, Bonnie ; Bouvy, Nicole D. ; Schreinemacher, Marc H.F. ; van Barneveld, Kevin ; Ploeg, Arianne J. ; Contant, C. ; van der Harst, Erwin ; de Rooij, Peter D. ; Deelman, Tara ; van Hout, Naomi ; Stasssen, Laurents P.S. ; Go, Peter M.N.Y.H. ; Roumen, R. ; Simons, Maarten P. ; Schreurs, Hermien W.H. ; Keyzer-Dekker, Claudia M.G. ; Takkenberg, Marijn ; Ugahary, Franz ; Liqui Lung, Paul F. ; de Roos, Marnix A.J. ; Ong, Paul K.H. ; Wijffels, Rob T.M. ; Vierhout, Bas P. ; Donse, Irene F. ; Pierik, E.G.J.M. ; Buijk, Steven ; Dawson, Imro ; Kloppenberg, Frank ; van den Broek, Rob W.F.R. ; van Geloven, A. ; Postema, Roelf R. ; Cate, W. Ten ; Rakic, Serdjan ; Schoenmaeckers, Ernst J.P. ; Plaisier, Peter W. ; Berendes, Thomas ; Oostenbroek, Rob J. ; Poyck, Paul P.C. ; van Geffen, Erwin H.J.A.A. ; Ruurda, Jelle ; Smulders, Frans J.F. ; Pierik, Robert E.G.J.M. ; Miserez, Marc ; Haers, Paul ; Mulier, Karel</creator><creatorcontrib>Van den Dop, L. Matthijs ; Van Egmond, Sarah ; Heijne, Jort ; Heijne, Jort ; van Rosmalen, Joost ; de Goede, Barry ; Wijsmuller, Arthur R. ; Kleinrensink, Gert-Jan ; Tanis, Pieter J. ; Jeekel, Johannes ; Lange, Johan F. ; Lange, Johan F. ; van den Dop, Matthijs ; van Egmond, Sarah ; van Rosmalen, Joost ; Tanis, Pieter ; de Goede, Barry ; Kleinrensink, Gert-Jan ; Jeekel, Johannes ; Van Ramshorst, Gabrielle H. ; Klitsie, Pieter J. ; van Kempen, Bob J.H. ; Hunink, Myriam G.M. ; Hop, Wim C. ; Halm, Jens A. ; Burger, Pim J.W.A. ; Brandt, Alexandra ; Franssen, Gaston J.H. ; Oomen, Jan ; Wijsmuller, Arthur R. ; Roumen, Rudi M.H. ; Schelting, Marc R.M. ; Boelens, Oliver ; Susa, Denis ; Verhagen, Tim ; Rath, Hiltjo J. ; Lont, Harold E. ; Mannaerts, Guido H. ; de Haan, Jeroen ; Mastboom, Walter ; Swank, Dingeman J. ; Schmitz, Roderick F. ; Zijsling, Bonnie ; Bouvy, Nicole D. ; Schreinemacher, Marc H.F. ; van Barneveld, Kevin ; Ploeg, Arianne J. ; Contant, C. ; van der Harst, Erwin ; de Rooij, Peter D. ; Deelman, Tara ; van Hout, Naomi ; Stasssen, Laurents P.S. ; Go, Peter M.N.Y.H. ; Roumen, R. ; Simons, Maarten P. ; Schreurs, Hermien W.H. ; Keyzer-Dekker, Claudia M.G. ; Takkenberg, Marijn ; Ugahary, Franz ; Liqui Lung, Paul F. ; de Roos, Marnix A.J. ; Ong, Paul K.H. ; Wijffels, Rob T.M. ; Vierhout, Bas P. ; Donse, Irene F. ; Pierik, E.G.J.M. ; Buijk, Steven ; Dawson, Imro ; Kloppenberg, Frank ; van den Broek, Rob W.F.R. ; van Geloven, A. ; Postema, Roelf R. ; Cate, W. Ten ; Rakic, Serdjan ; Schoenmaeckers, Ernst J.P. ; Plaisier, Peter W. ; Berendes, Thomas ; Oostenbroek, Rob J. ; Poyck, Paul P.C. ; van Geffen, Erwin H.J.A.A. ; Ruurda, Jelle ; Smulders, Frans J.F. ; Pierik, Robert E.G.J.M. ; Miserez, Marc ; Haers, Paul ; Mulier, Karel ; INCA Trialists' Collaboration</creatorcontrib><description>Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.
In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629.
Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%).
During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.
The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.</description><identifier>ISSN: 2589-5370</identifier><identifier>EISSN: 2589-5370</identifier><identifier>DOI: 10.1016/j.eclinm.2023.102207</identifier><identifier>PMID: 37936657</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Crossover ; Herniorrhaphy ; Inguinal hernia ; Recurrence ; Watchful waiting</subject><ispartof>EClinicalMedicine, 2023-10, Vol.64, p.102207, Article 102207</ispartof><rights>2023 The Author(s)</rights><rights>2023 The Author(s).</rights><rights>2023 The Author(s) 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-3582f9bad56ed7376ff2ea0073e4e42ef426c4886e118de5ab3ce7dc58cb93713</citedby><cites>FETCH-LOGICAL-c464t-3582f9bad56ed7376ff2ea0073e4e42ef426c4886e118de5ab3ce7dc58cb93713</cites><orcidid>0000-0002-9187-244X ; 0000-0001-6957-3614</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10626166/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10626166/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37936657$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Van den Dop, L. Matthijs</creatorcontrib><creatorcontrib>Van Egmond, Sarah</creatorcontrib><creatorcontrib>Heijne, Jort</creatorcontrib><creatorcontrib>Heijne, Jort</creatorcontrib><creatorcontrib>van Rosmalen, Joost</creatorcontrib><creatorcontrib>de Goede, Barry</creatorcontrib><creatorcontrib>Wijsmuller, Arthur R.</creatorcontrib><creatorcontrib>Kleinrensink, Gert-Jan</creatorcontrib><creatorcontrib>Tanis, Pieter J.</creatorcontrib><creatorcontrib>Jeekel, Johannes</creatorcontrib><creatorcontrib>Lange, Johan F.</creatorcontrib><creatorcontrib>Lange, Johan F.</creatorcontrib><creatorcontrib>van den Dop, Matthijs</creatorcontrib><creatorcontrib>van Egmond, Sarah</creatorcontrib><creatorcontrib>van Rosmalen, Joost</creatorcontrib><creatorcontrib>Tanis, Pieter</creatorcontrib><creatorcontrib>de Goede, Barry</creatorcontrib><creatorcontrib>Kleinrensink, Gert-Jan</creatorcontrib><creatorcontrib>Jeekel, Johannes</creatorcontrib><creatorcontrib>Van Ramshorst, Gabrielle H.</creatorcontrib><creatorcontrib>Klitsie, Pieter J.</creatorcontrib><creatorcontrib>van Kempen, Bob J.H.</creatorcontrib><creatorcontrib>Hunink, Myriam G.M.</creatorcontrib><creatorcontrib>Hop, Wim C.</creatorcontrib><creatorcontrib>Halm, Jens A.</creatorcontrib><creatorcontrib>Burger, Pim J.W.A.</creatorcontrib><creatorcontrib>Brandt, Alexandra</creatorcontrib><creatorcontrib>Franssen, Gaston J.H.</creatorcontrib><creatorcontrib>Oomen, Jan</creatorcontrib><creatorcontrib>Wijsmuller, Arthur R.</creatorcontrib><creatorcontrib>Roumen, Rudi M.H.</creatorcontrib><creatorcontrib>Schelting, Marc R.M.</creatorcontrib><creatorcontrib>Boelens, Oliver</creatorcontrib><creatorcontrib>Susa, Denis</creatorcontrib><creatorcontrib>Verhagen, Tim</creatorcontrib><creatorcontrib>Rath, Hiltjo J.</creatorcontrib><creatorcontrib>Lont, Harold E.</creatorcontrib><creatorcontrib>Mannaerts, Guido H.</creatorcontrib><creatorcontrib>de Haan, Jeroen</creatorcontrib><creatorcontrib>Mastboom, Walter</creatorcontrib><creatorcontrib>Swank, Dingeman J.</creatorcontrib><creatorcontrib>Schmitz, Roderick F.</creatorcontrib><creatorcontrib>Zijsling, Bonnie</creatorcontrib><creatorcontrib>Bouvy, Nicole D.</creatorcontrib><creatorcontrib>Schreinemacher, Marc H.F.</creatorcontrib><creatorcontrib>van Barneveld, Kevin</creatorcontrib><creatorcontrib>Ploeg, Arianne J.</creatorcontrib><creatorcontrib>Contant, C.</creatorcontrib><creatorcontrib>van der Harst, Erwin</creatorcontrib><creatorcontrib>de Rooij, Peter D.</creatorcontrib><creatorcontrib>Deelman, Tara</creatorcontrib><creatorcontrib>van Hout, Naomi</creatorcontrib><creatorcontrib>Stasssen, Laurents P.S.</creatorcontrib><creatorcontrib>Go, Peter M.N.Y.H.</creatorcontrib><creatorcontrib>Roumen, R.</creatorcontrib><creatorcontrib>Simons, Maarten P.</creatorcontrib><creatorcontrib>Schreurs, Hermien W.H.</creatorcontrib><creatorcontrib>Keyzer-Dekker, Claudia M.G.</creatorcontrib><creatorcontrib>Takkenberg, Marijn</creatorcontrib><creatorcontrib>Ugahary, Franz</creatorcontrib><creatorcontrib>Liqui Lung, Paul F.</creatorcontrib><creatorcontrib>de Roos, Marnix A.J.</creatorcontrib><creatorcontrib>Ong, Paul K.H.</creatorcontrib><creatorcontrib>Wijffels, Rob T.M.</creatorcontrib><creatorcontrib>Vierhout, Bas P.</creatorcontrib><creatorcontrib>Donse, Irene F.</creatorcontrib><creatorcontrib>Pierik, E.G.J.M.</creatorcontrib><creatorcontrib>Buijk, Steven</creatorcontrib><creatorcontrib>Dawson, Imro</creatorcontrib><creatorcontrib>Kloppenberg, Frank</creatorcontrib><creatorcontrib>van den Broek, Rob W.F.R.</creatorcontrib><creatorcontrib>van Geloven, A.</creatorcontrib><creatorcontrib>Postema, Roelf R.</creatorcontrib><creatorcontrib>Cate, W. Ten</creatorcontrib><creatorcontrib>Rakic, Serdjan</creatorcontrib><creatorcontrib>Schoenmaeckers, Ernst J.P.</creatorcontrib><creatorcontrib>Plaisier, Peter W.</creatorcontrib><creatorcontrib>Berendes, Thomas</creatorcontrib><creatorcontrib>Oostenbroek, Rob J.</creatorcontrib><creatorcontrib>Poyck, Paul P.C.</creatorcontrib><creatorcontrib>van Geffen, Erwin H.J.A.A.</creatorcontrib><creatorcontrib>Ruurda, Jelle</creatorcontrib><creatorcontrib>Smulders, Frans J.F.</creatorcontrib><creatorcontrib>Pierik, Robert E.G.J.M.</creatorcontrib><creatorcontrib>Miserez, Marc</creatorcontrib><creatorcontrib>Haers, Paul</creatorcontrib><creatorcontrib>Mulier, Karel</creatorcontrib><creatorcontrib>INCA Trialists' Collaboration</creatorcontrib><title>Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older: a randomised controlled trial</title><title>EClinicalMedicine</title><addtitle>EClinicalMedicine</addtitle><description>Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.
In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629.
Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%).
During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.
The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.</description><subject>Crossover</subject><subject>Herniorrhaphy</subject><subject>Inguinal hernia</subject><subject>Recurrence</subject><subject>Watchful waiting</subject><issn>2589-5370</issn><issn>2589-5370</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9Uctu3CAUtapWTZTmD6KKZTeeYrDB7qJVFfUlRcomWSMGrmcY8ZgCnsh_0w_oV_TLyshpNN1kxT2Xc869cKrqqsGrBjfs_W4FyhrvVgQTWlqEYP6iOiddP9Qd5fjlSX1WXaa0wxgT3PYDw6-rM8oHyljHz6vfdw9gD1DPICMKU1bBQUJhRA8yq-042VKYbPwGHSCmKaE0xQ3E-Uhxxmo7ozS7fQ5OZqNQiEie4iKcjJcWbSF6IwtGDjySG9Cow39-HccmJL1GwWqIH5BEsaDgTCoMFXyOwdpS5mikfVO9GqVNcPl4XlT3X7_cXX-vb26__bj-fFOrlrW5pl1PxmEtdcdAc8rZOBKQGHMKLbQExpYw1fY9g6bpNXRyTRVwrbperQfKG3pRfVp899PagVZQ1pBW7KNxMs4iSCP-v_FmKzbhIBrMCGsYKw7vHh1i-DlByqK8SIG10kOYkiB9z1vekQEXartQVQwpRRif5jRYHMMWO7GELY5hiyXsInt7uuOT6F-0hfBxIUD5qYOBKJIy4BVoE0FloYN5fsJfrj_DOQ</recordid><startdate>20231001</startdate><enddate>20231001</enddate><creator>Van den Dop, L. Matthijs</creator><creator>Van Egmond, Sarah</creator><creator>Heijne, Jort</creator><creator>Heijne, Jort</creator><creator>van Rosmalen, Joost</creator><creator>de Goede, Barry</creator><creator>Wijsmuller, Arthur R.</creator><creator>Kleinrensink, Gert-Jan</creator><creator>Tanis, Pieter J.</creator><creator>Jeekel, Johannes</creator><creator>Lange, Johan F.</creator><creator>Lange, Johan F.</creator><creator>van den Dop, Matthijs</creator><creator>van Egmond, Sarah</creator><creator>van Rosmalen, Joost</creator><creator>Tanis, Pieter</creator><creator>de Goede, Barry</creator><creator>Kleinrensink, Gert-Jan</creator><creator>Jeekel, Johannes</creator><creator>Van Ramshorst, Gabrielle H.</creator><creator>Klitsie, Pieter J.</creator><creator>van Kempen, Bob J.H.</creator><creator>Hunink, Myriam G.M.</creator><creator>Hop, Wim C.</creator><creator>Halm, Jens A.</creator><creator>Burger, Pim J.W.A.</creator><creator>Brandt, Alexandra</creator><creator>Franssen, Gaston J.H.</creator><creator>Oomen, Jan</creator><creator>Wijsmuller, Arthur R.</creator><creator>Roumen, Rudi M.H.</creator><creator>Schelting, Marc R.M.</creator><creator>Boelens, Oliver</creator><creator>Susa, Denis</creator><creator>Verhagen, Tim</creator><creator>Rath, Hiltjo J.</creator><creator>Lont, Harold E.</creator><creator>Mannaerts, Guido H.</creator><creator>de Haan, Jeroen</creator><creator>Mastboom, Walter</creator><creator>Swank, Dingeman J.</creator><creator>Schmitz, Roderick F.</creator><creator>Zijsling, Bonnie</creator><creator>Bouvy, Nicole D.</creator><creator>Schreinemacher, Marc H.F.</creator><creator>van Barneveld, Kevin</creator><creator>Ploeg, Arianne J.</creator><creator>Contant, C.</creator><creator>van der Harst, Erwin</creator><creator>de Rooij, Peter D.</creator><creator>Deelman, Tara</creator><creator>van Hout, Naomi</creator><creator>Stasssen, Laurents P.S.</creator><creator>Go, Peter M.N.Y.H.</creator><creator>Roumen, R.</creator><creator>Simons, Maarten P.</creator><creator>Schreurs, Hermien W.H.</creator><creator>Keyzer-Dekker, Claudia M.G.</creator><creator>Takkenberg, Marijn</creator><creator>Ugahary, Franz</creator><creator>Liqui Lung, Paul F.</creator><creator>de Roos, Marnix A.J.</creator><creator>Ong, Paul K.H.</creator><creator>Wijffels, Rob T.M.</creator><creator>Vierhout, Bas P.</creator><creator>Donse, Irene F.</creator><creator>Pierik, E.G.J.M.</creator><creator>Buijk, Steven</creator><creator>Dawson, Imro</creator><creator>Kloppenberg, Frank</creator><creator>van den Broek, Rob W.F.R.</creator><creator>van Geloven, A.</creator><creator>Postema, Roelf R.</creator><creator>Cate, W. Ten</creator><creator>Rakic, Serdjan</creator><creator>Schoenmaeckers, Ernst J.P.</creator><creator>Plaisier, Peter W.</creator><creator>Berendes, Thomas</creator><creator>Oostenbroek, Rob J.</creator><creator>Poyck, Paul P.C.</creator><creator>van Geffen, Erwin H.J.A.A.</creator><creator>Ruurda, Jelle</creator><creator>Smulders, Frans J.F.</creator><creator>Pierik, Robert E.G.J.M.</creator><creator>Miserez, Marc</creator><creator>Haers, Paul</creator><creator>Mulier, Karel</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-9187-244X</orcidid><orcidid>https://orcid.org/0000-0001-6957-3614</orcidid></search><sort><creationdate>20231001</creationdate><title>Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older: a randomised controlled trial</title><author>Van den Dop, L. Matthijs ; Van Egmond, Sarah ; Heijne, Jort ; Heijne, Jort ; van Rosmalen, Joost ; de Goede, Barry ; Wijsmuller, Arthur R. ; Kleinrensink, Gert-Jan ; Tanis, Pieter J. ; Jeekel, Johannes ; Lange, Johan F. ; Lange, Johan F. ; van den Dop, Matthijs ; van Egmond, Sarah ; van Rosmalen, Joost ; Tanis, Pieter ; de Goede, Barry ; Kleinrensink, Gert-Jan ; Jeekel, Johannes ; Van Ramshorst, Gabrielle H. ; Klitsie, Pieter J. ; van Kempen, Bob J.H. ; Hunink, Myriam G.M. ; Hop, Wim C. ; Halm, Jens A. ; Burger, Pim J.W.A. ; Brandt, Alexandra ; Franssen, Gaston J.H. ; Oomen, Jan ; Wijsmuller, Arthur R. ; Roumen, Rudi M.H. ; Schelting, Marc R.M. ; Boelens, Oliver ; Susa, Denis ; Verhagen, Tim ; Rath, Hiltjo J. ; Lont, Harold E. ; Mannaerts, Guido H. ; de Haan, Jeroen ; Mastboom, Walter ; Swank, Dingeman J. ; Schmitz, Roderick F. ; Zijsling, Bonnie ; Bouvy, Nicole D. ; Schreinemacher, Marc H.F. ; van Barneveld, Kevin ; Ploeg, Arianne J. ; Contant, C. ; van der Harst, Erwin ; de Rooij, Peter D. ; Deelman, Tara ; van Hout, Naomi ; Stasssen, Laurents P.S. ; Go, Peter M.N.Y.H. ; Roumen, R. ; Simons, Maarten P. ; Schreurs, Hermien W.H. ; Keyzer-Dekker, Claudia M.G. ; Takkenberg, Marijn ; Ugahary, Franz ; Liqui Lung, Paul F. ; de Roos, Marnix A.J. ; Ong, Paul K.H. ; Wijffels, Rob T.M. ; Vierhout, Bas P. ; Donse, Irene F. ; Pierik, E.G.J.M. ; Buijk, Steven ; Dawson, Imro ; Kloppenberg, Frank ; van den Broek, Rob W.F.R. ; van Geloven, A. ; Postema, Roelf R. ; Cate, W. Ten ; Rakic, Serdjan ; Schoenmaeckers, Ernst J.P. ; Plaisier, Peter W. ; Berendes, Thomas ; Oostenbroek, Rob J. ; Poyck, Paul P.C. ; van Geffen, Erwin H.J.A.A. ; Ruurda, Jelle ; Smulders, Frans J.F. ; Pierik, Robert E.G.J.M. ; Miserez, Marc ; Haers, Paul ; Mulier, Karel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-3582f9bad56ed7376ff2ea0073e4e42ef426c4886e118de5ab3ce7dc58cb93713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Crossover</topic><topic>Herniorrhaphy</topic><topic>Inguinal hernia</topic><topic>Recurrence</topic><topic>Watchful waiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Van den Dop, L. 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Matthijs</au><au>Van Egmond, Sarah</au><au>Heijne, Jort</au><au>Heijne, Jort</au><au>van Rosmalen, Joost</au><au>de Goede, Barry</au><au>Wijsmuller, Arthur R.</au><au>Kleinrensink, Gert-Jan</au><au>Tanis, Pieter J.</au><au>Jeekel, Johannes</au><au>Lange, Johan F.</au><au>Lange, Johan F.</au><au>van den Dop, Matthijs</au><au>van Egmond, Sarah</au><au>van Rosmalen, Joost</au><au>Tanis, Pieter</au><au>de Goede, Barry</au><au>Kleinrensink, Gert-Jan</au><au>Jeekel, Johannes</au><au>Van Ramshorst, Gabrielle H.</au><au>Klitsie, Pieter J.</au><au>van Kempen, Bob J.H.</au><au>Hunink, Myriam G.M.</au><au>Hop, Wim C.</au><au>Halm, Jens A.</au><au>Burger, Pim J.W.A.</au><au>Brandt, Alexandra</au><au>Franssen, Gaston J.H.</au><au>Oomen, Jan</au><au>Wijsmuller, Arthur R.</au><au>Roumen, Rudi M.H.</au><au>Schelting, Marc R.M.</au><au>Boelens, Oliver</au><au>Susa, Denis</au><au>Verhagen, Tim</au><au>Rath, Hiltjo J.</au><au>Lont, Harold E.</au><au>Mannaerts, Guido H.</au><au>de Haan, Jeroen</au><au>Mastboom, Walter</au><au>Swank, Dingeman J.</au><au>Schmitz, Roderick F.</au><au>Zijsling, Bonnie</au><au>Bouvy, Nicole D.</au><au>Schreinemacher, Marc H.F.</au><au>van Barneveld, Kevin</au><au>Ploeg, Arianne J.</au><au>Contant, C.</au><au>van der Harst, Erwin</au><au>de Rooij, Peter D.</au><au>Deelman, Tara</au><au>van Hout, Naomi</au><au>Stasssen, Laurents P.S.</au><au>Go, Peter M.N.Y.H.</au><au>Roumen, R.</au><au>Simons, Maarten P.</au><au>Schreurs, Hermien W.H.</au><au>Keyzer-Dekker, Claudia M.G.</au><au>Takkenberg, Marijn</au><au>Ugahary, Franz</au><au>Liqui Lung, Paul F.</au><au>de Roos, Marnix A.J.</au><au>Ong, Paul K.H.</au><au>Wijffels, Rob T.M.</au><au>Vierhout, Bas P.</au><au>Donse, Irene F.</au><au>Pierik, E.G.J.M.</au><au>Buijk, Steven</au><au>Dawson, Imro</au><au>Kloppenberg, Frank</au><au>van den Broek, Rob W.F.R.</au><au>van Geloven, A.</au><au>Postema, Roelf R.</au><au>Cate, W. Ten</au><au>Rakic, Serdjan</au><au>Schoenmaeckers, Ernst J.P.</au><au>Plaisier, Peter W.</au><au>Berendes, Thomas</au><au>Oostenbroek, Rob J.</au><au>Poyck, Paul P.C.</au><au>van Geffen, Erwin H.J.A.A.</au><au>Ruurda, Jelle</au><au>Smulders, Frans J.F.</au><au>Pierik, Robert E.G.J.M.</au><au>Miserez, Marc</au><au>Haers, Paul</au><au>Mulier, Karel</au><aucorp>INCA Trialists' Collaboration</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older: a randomised controlled trial</atitle><jtitle>EClinicalMedicine</jtitle><addtitle>EClinicalMedicine</addtitle><date>2023-10-01</date><risdate>2023</risdate><volume>64</volume><spage>102207</spage><pages>102207-</pages><artnum>102207</artnum><issn>2589-5370</issn><eissn>2589-5370</eissn><abstract>Inguinal hernia belongs to the most common surgical pathology worldwide. Approximately, one third is asymptomatic. The value of watchful waiting (WW) in patients with asymptomatic or mildly symptomatic inguinal hernia has been established in a few randomised controlled trials (RCTs). The aim of this study was to assess long-term outcomes of a RCT comparing WW and elective surgery.
In the original study, men aged ≥50 years with an asymptomatic or mildly symptomatic inguinal hernia were randomly assigned to WW or elective repair. In the present study, the primary outcome was the 12-year crossover rate to surgery, secondary outcomes were time-to-crossover, patient regret, pain, quality of life and incarceration. Dutch Trial Registry: NTR629.
Out of 496 originally analysed patients, 488 (98.4%) were evaluable for chart review (WW: n = 258, surgery: n = 230), and 200 (41.0%) for telephone contact (WW: n = 106, surgery: n = 94) between November 2021 and March 2022 with a median 12 years follow-up (IQR 9–14). After 12 years, the estimated cumulative crossover rate to surgery was 64.2%, which was higher in mildly symptomatic than in asymptomatic patients (71.7% versus 60.4%, HR 1.451, 95% CI: 1.064–1.979). Time-to-crossover was longer in asymptomatic patients (50% after 6.0 years versus 2.0 years, p = 0.019). Patient regret was higher in the WW group (37.7 versus 18.0%, p = 0.002), as well as pain/discomfort (p = 0.031). Quality of life did not differ (p = 0.737). In the WW group, incarceration occurred in 10/255 patients (3.9%).
During 12-year follow-up, most WW patients crossed over to surgery, significantly earlier with mildly symptomatic hernia. Considering the relatively low incarceration rate, WW might still be an option in asymptomatic patients with a clear preference and being well-informed about pros and cons.
The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>37936657</pmid><doi>10.1016/j.eclinm.2023.102207</doi><orcidid>https://orcid.org/0000-0002-9187-244X</orcidid><orcidid>https://orcid.org/0000-0001-6957-3614</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2589-5370 |
| ispartof | EClinicalMedicine, 2023-10, Vol.64, p.102207, Article 102207 |
| issn | 2589-5370 2589-5370 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10626166 |
| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection |
| subjects | Crossover Herniorrhaphy Inguinal hernia Recurrence Watchful waiting |
| title | Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older: a randomised controlled trial |
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