TY - JOUR
T1 - Twelve-year outcomes of watchful waiting versus surgery of mildly symptomatic or asymptomatic inguinal hernia in men aged 50 years and older
T2 - a randomised controlled trial
AU - van den Dop, L. Matthijs
AU - INCA Trialists' Collaboration
AU - van Egmond, Sarah
AU - Heijne, Jort
AU - van Rosmalen, Joost
AU - de Goede, Barry
AU - Wijsmuller, Arthur R.
AU - Kleinrensink, Gert-Jan
AU - Tanis, Pieter J.
AU - Jeekel, Johannes
AU - Lange, Johan F.
AU - van den Dop, Matthijs
AU - Tanis, Pieter
AU - Klitsie, Pieter J.
AU - van Kempen, Bob J. H.
AU - Hunink, Myriam G. M.
AU - Hop, Wim C.
AU - Halm, Jens A.
AU - Burger, Pim J. W. A.
AU - Brandt, Alexandra
AU - Franssen, Gaston J. H.
AU - Oomen, Jan
AU - Roumen, Rudi M. H.
AU - Scheltinga, Marc R. M.
AU - Boelens, Oliver
AU - Susa, Denis
AU - Verhagen, Tim
AU - Rath, Hiltjo J.
AU - Lont, Harold E.
AU - Mannaerts, Guido H.
AU - Haan, Jeroen de
AU - Mastboom, Walter
AU - Swank, Dingeman J.
AU - Schmitz, Roderick F.
AU - Zijsling, Bonnie
AU - Bouvy, Nicole D.
AU - Schreinemacher, Marc H. F.
AU - van Barneveld, Kevin
AU - Ploeg, Arianne J.
AU - Contant, C.
AU - van der Harst, Erwin
AU - de Rooij, Peter D.
AU - Deelman, Tara
AU - van Hout, Naomi
AU - Stasssen, Laurents P. S.
AU - Go, Peter M. N. Y. H.
AU - Simons, Maarten P.
AU - Schreurs, Hermien W. H.
AU - Keyzer-Dekker, Claudia M. G.
AU - Postema, Roelf R.
AU - Ruurda, Jelle
AU - Poyck, Paul P. C.
N1 - Funding Information: The initial trial was funded by the Netherlands Organisation for HealthResearch and Development (ZonMW). This long-term study did not receive funding. The funders had no role in study design, conducting of the study, data collection, data analysis, data interpretation, or writing of the report. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. Publisher Copyright: © 2023 The Author(s)
PY - 2023/10
Y1 - 2023/10
N2 - Background: 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. Methods: 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. Findings: 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%). Interpretation: 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. Funding: The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.
AB - Background: 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. Methods: 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. Findings: 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%). Interpretation: 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. Funding: The initial trial was funded by the Netherlands Organisation for Health Research and Development (ZonMW). This long-term study did not receive funding.
KW - Crossover
KW - Herniorrhaphy
KW - Inguinal hernia
KW - Recurrence
KW - Watchful waiting
UR - http://www.scopus.com/inward/record.url?scp=85173150224&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.eclinm.2023.102207
DO - https://doi.org/10.1016/j.eclinm.2023.102207
M3 - Article
C2 - 37936657
SN - 2589-5370
VL - 64
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102207
ER -