Tags

Type your tag names separated by a space and hit enter

Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial.
Ann Surg 2018; 267(1):42-49AnnS

Abstract

OBJECTIVE

To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia.

BACKGROUND

The role of watchful waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established.

METHODS

In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates.

RESULTS

Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria: 234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 [95% confidence interval (CI) 0.28-0.41)] in the elective repair group and 0.58 (95% CI 0.52-0.64) in the watchful waiting group. The difference of these means (MD) was -0.23 (95% CI -0.32 to -0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively).

CONCLUSIONS

Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older.

Authors+Show Affiliations

Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.Department of Surgery, VU University Medical Center, Amsterdam, The Netherlands.Department of Epidemiology and Radiology, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Biostatistics, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Orthopaedic Surgery, Haga Hospital, Den Haag, The Netherlands.Department of Surgery, Maxima Medical Center/SolviMax, Veldhoven/Eindhoven, The Netherlands.Department of Surgery, Westfries Hospital, Hoorn, The Netherlands.Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.Department of Surgery, Maasstad Hospital, Rotterdam, The Netherlands.Department of Surgery, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands.Department of Neuroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Neuroscience, Erasmus University Medical Center, Rotterdam, The Netherlands.Department of Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28350567

Citation

de Goede, Barry, et al. "Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: a Randomized Controlled Trial." Annals of Surgery, vol. 267, no. 1, 2018, pp. 42-49.
de Goede B, Wijsmuller AR, van Ramshorst GH, et al. Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial. Ann Surg. 2018;267(1):42-49.
de Goede, B., Wijsmuller, A. R., van Ramshorst, G. H., van Kempen, B. J., Hop, W. C. J., Klitsie, P. J., ... Lange, J. F. (2018). Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial. Annals of Surgery, 267(1), pp. 42-49. doi:10.1097/SLA.0000000000002243.
de Goede B, et al. Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: a Randomized Controlled Trial. Ann Surg. 2018;267(1):42-49. PubMed PMID: 28350567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial. AU - de Goede,Barry, AU - Wijsmuller,Arthur R, AU - van Ramshorst,Gabrielle H, AU - van Kempen,Bob J, AU - Hop,Wim C J, AU - Klitsie,Pieter J, AU - Scheltinga,Marc R, AU - de Haan,Jeroen, AU - Mastboom,Walter J B, AU - van der Harst,Erwin, AU - Simons,Maarten P, AU - Kleinrensink,Gert-Jan, AU - Jeekel,Johannes, AU - Lange,Johan F, AU - ,, PY - 2017/3/30/pubmed PY - 2017/12/27/medline PY - 2017/3/29/entrez SP - 42 EP - 49 JF - Annals of surgery JO - Ann. Surg. VL - 267 IS - 1 N2 - OBJECTIVE: To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia. BACKGROUND: The role of watchful waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established. METHODS: In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates. RESULTS: Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria: 234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 [95% confidence interval (CI) 0.28-0.41)] in the elective repair group and 0.58 (95% CI 0.52-0.64) in the watchful waiting group. The difference of these means (MD) was -0.23 (95% CI -0.32 to -0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively). CONCLUSIONS: Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older. SN - 1528-1140 UR - https://www.unboundmedicine.com/medline/citation/28350567/Watchful_Waiting_Versus_Surgery_of_Mildly_Symptomatic_or_Asymptomatic_Inguinal_Hernia_in_Men_Aged_50_Years_and_Older:_A_Randomized_Controlled_Trial_ L2 - http://Insights.ovid.com/pubmed?pmid=28350567 DB - PRIME DP - Unbound Medicine ER -