Operative versus conservative management for inguinal hernia: a methodology scoping review of randomized controlled trials.

Introduction: There is a lack of consensus on the management of inguinal hernia with limited symptoms. To address this issue a systematic review of existing randomized clinical trials (RCTs) was performed to critically appraise all existing data on asymptomatic hernia management, focusing on generalizability.

Methods: A scoping review to identify all RCTs comparing surgical and conservative management of patients with inguinal hernias was undertaken. Medline, Embase, Cochrane and ClinicalTrials.gov databases were searched. Data collected included study characteristics and definitions of population, intervention/comparator, and outcomes; and limitations of each study were also extracted. The quality and generalizability of included RCTs were evaluated using Cochrane's ROB-2 and the PRECIS-2 tool, respectively.

Results: Searches returned 661 papers; 14 full-text papers were assessed and three RCTs were identified. All RCTs included only male patients with a mean age above 55 years. All RCTs included asymptomatic patients and two included those with minimal symptoms. Different definitions for 'minimally symptomatic' were used in RCTs and none provided details of what was meant by conservative treatment. Follow-up periods varied between studies (1, 2, 3 years). All RCTs had an overall high risk of bias. According to PRECIS-2, two RCTs were classified as pragmatic, and one was equally pragmatic and explanatory.

Discussion: This systematic review highlights a high risk of bias but a good generalizability of the findings from the RCTs conducted on minimally symptomatic inguinal hernia patients. To improve the guidelines for the management of this group of patients, more generalizable data are needed.