Trial reportSurgical endoscopy2025
Watchful waiting versus totally extraperitoneal (TEP) hernia repair for occult inguinal hernia and pain (EFFECT trial)-a multicenter, non-inferiority, randomized controlled trial.
Trial report in Surgical endoscopy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Watchful waiting vs. early repair for asymptomatic and mildly symptomatic inguinal hernia - silent hernia, loud debate: a qualitative systematic review.Hernia : the journal of hernias and abdominal wall surgery · 2025Pooled it
- Comparative efficacy and safety of surgical techniques for inguinal hernia repair in elderly patients: a network meta-analysis.Frontiers in surgery · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundCurrent international guidelines offer no specific recommendations for managing occult inguinal hernias with groin pain, often resulting in unnecessary repairs. This randomized controlled trial (RCT) evaluated whether watchful waiting (WW) is non-inferior to totally extraperitoneal (TEP) repair in this distinct patient population.
methodsFrom December 29, 2017, to March 4, 2022, this multicenter, non-inferiority RCT screened all adult patients with unilateral groin pain (numeric rating scale [NRS] ≥ 1) without a clinically evident inguinal hernia. Patients allocated to the WW arm were treated with rest, analgesics, or physiotherapy, while those assigned to surgery underwent TEP repair. The sample size was 80 patients per arm (non-inferiority margin: 0.75 NRS; 1-sided alpha: 0.025; beta: 0.10; loss to follow-up: 10%). The primary outcome was the mean NRS difference between baseline and 3 months of follow-up, measured at rest and during exercise, and analyzed using a mixed-effects model. Total follow-up was 12 months. Secondary outcomes included quality of life, patient satisfaction, and crossover rate.
resultsFrom a total of 99 patients, 85 patients were included in the study (WW: 49; TEP: 36). The analysis showed a mean difference of 0.644 (97.5% CI: - 0.321 to 1.610) for pain at rest and 0.806 (97.5% CI: - 0.402 to 2.014) for pain during exercise. Crossover from WW to TEP occurred in five patients (10%). Secondary outcomes were similar between the groups up to 3 months.
conclusionThis trial failed to demonstrate non-inferiority of WW compared to TEP repair for pain relief at 3 months post-intervention in patients with groin pain and an occult inguinal hernia. However, this result does not confirm that WW is inferior, as secondary outcomes were comparable up to 3 months and upfront TEP repair carried a risk of overtreatment. Therefore, a WW strategy for at least 3 months may be justified as a diagnostic tool to determine which patients may benefit from surgery.
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