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

L. Matthijs Van den Dop*, Sarah Van Egmond, Jort Heijne, Joost van Rosmalen, Barry de Goede, Arthur R. Wijsmuller, Gert Jan Kleinrensink, Pieter J. Tanis, Johannes Jeekel, Johan F. Lange, Pieter J. Klitsie, Bob J.H. van Kempen, INCA Trialists' Collaboration, Myriam G.M. Hunink, Wim C. Hop, Jens A. Halm, Pim J.W.A. Burger, Alexandra Brandt, Gaston J.H. Franssen, Jan OomenRudi M.H. Roumen, Marc R.M. Scheltinga, Oliver Boelens, Denis Susa, Tim Verhagen, Hiltjo J. Rath, Harold E. Lont, Guido H. Mannaerts, Jeroen de Haan, Walter Mastboom, Dingeman J. Swank, Roderick F. Schmitz, Bonnie Zijsling, Nicole D. Bouvy, Marc H.F. Schreinemacher, Kevin van Barneveld, Arianne J. Ploeg, C. Contant, Erwin van der Harst, Peter D. de Rooij, Tara Deelman, Naomi van Hout, Laurents P.S. Stasssen, Peter M.N.Y.H. Go, Maarten P. Simons, Claudia M.G. Keyzer-Dekker, E. G.J.M. Pierik, Steven Buijk, Imro Dawson

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Article number102207
JournalEClinicalMedicine
Volume64
Early online date14 Sept 2023
DOIs
Publication statusPublished - Oct 2023

Bibliographical note

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)

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