Unité de chirurgie viscérale et digestive, Hôpital privé d'Antony, Ramsay-GDS, 1, rue Velpeau, 92160, Antony, France.
Polyclinique St Jean, 92, avenue Dr M. Donat, 06800, Cagnes/mer, France.
Langenbecks Arch Surg. 2021 Feb;406(1):197-208. doi: 10.1007/s00423-020-01993-x. Epub 2020 Sep 30.
Onflex™ mesh has replaced Polysoft™ patch on the market, without being clinically evaluated thus far in the transinguinal preperitoneal (TIPP) technique.
All consecutive TIPP registered in our registry during the overlap period of availability of both meshes were included and studied with the chronic postoperative inguinal pain (CPIP) as primary endpoint, assessed with a verbal rating scale (VRS), and included in a patient-related outcome measurement (PROM) phone questionnaire.
A total of 181 Onflex cases vs 182 Polysoft cases were studied with a 2-year follow-up rate of 92% vs 88%. The overall rate of pain or discomfort was not statistically different in the 2 studied subgroups (16.5% vs 17.6%; p = 0.71), while moderate or severe pain were significantly more frequent in the Polysoft subgroup (5.5% vs 11.6%; p = 0.01). These symptoms did not interfere with the patient daily life in 16% vs 16.5% of cases, and they were self-assessed as more bothersome than the hernia in only 0.5% vs 0.5% of cases, suggesting an overestimation of the pain by the VRS. Patients assessed the result of their hernia repair as excellent or good in 97.8% vs 96.7% and medium or bad in 2.2% vs 3.3% (p = 0.53). The cumulative recurrence rate was 0% vs 2.2%. Two reoperations (one for early and one for late recurrence) were reported in the Polysoft subgroup (1%), none related to the non-absorbable memory ring.
These results suggest that TIPP with Onflex provides results at least similar than those with Polysoft.
Onflex 网片已在市场上取代 Polysoft 补丁，但迄今为止尚未在经腹股沟腹膜前（TIPP）技术中进行临床评估。
在两种网片均可用的重叠期间，我们将所有连续登记的 TIPP 病例纳入研究，并将慢性腹股沟术后疼痛（CPIP）作为主要终点进行评估，使用口述评分量表（VRS）进行评估，并纳入患者相关结局测量（PROM）电话问卷。
共研究了 181 例 Onflex 病例和 182 例 Polysoft 病例，2 年随访率分别为 92%和 88%。在这两个研究亚组中，疼痛或不适的总体发生率无统计学差异（16.5% vs. 17.6%；p=0.71），而 Polysoft 亚组中度或重度疼痛更为频繁（5.5% vs. 11.6%；p=0.01）。这些症状在 16%的病例中不影响患者日常生活，在 16.5%的病例中患者自我评估这些症状比疝更麻烦，仅在 0.5%的病例中比 0.5%的病例更麻烦，这表明 VRS 对疼痛的评估过高。97.8%的患者评估其疝修补结果为优或良，2.2%的患者评估为中等或差；96.7%的患者评估结果为优或良，3.3%的患者评估为中等或差（p=0.53）。累积复发率为 0% vs. 2.2%。在 Polysoft 亚组中报告了 2 例再手术（1 例为早期复发，1 例为晚期复发）（1%），均与不可吸收记忆环无关。
这些结果表明，TIPP 使用 Onflex 提供的结果至少与使用 Polysoft 相似。
