Department of Surgery, Erasmus University Medical Center, Room Ee-1453, PO BOX 2040, 3000, CA, Rotterdam, The Netherlands.
Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.
Langenbecks Arch Surg. 2021 Feb;406(1):219-225. doi: 10.1007/s00423-020-02033-4. Epub 2020 Nov 25.
To establish optimal management of patients with an umbilical hernia complicated by liver cirrhosis and ascites.
Patients with an umbilical hernia and liver cirrhosis and ascites were randomly assigned to receive either elective repair or conservative treatment. The primary endpoint was overall morbidity related to the umbilical hernia or its treatment after 24 months of follow-up. Secondary endpoints included the severity of these hernia-related complications, quality of life, and cumulative hernia recurrence rate.
Thirty-four patients were included in the study. Sixteen patients were randomly assigned to elective repair and 18 to conservative treatment. After 24 months, 8 patients (50%) assigned to elective repair compared to 14 patients (77.8%) assigned to conservative treatment had a complication related to the umbilical hernia or its repair. A recurrent hernia was reported in 16.7% of patients who underwent repair. For the secondary endpoint, quality of life through the physical (PCS) and mental component score (MCS) showed no significant differences between groups at 12 months of follow-up (mean difference PCS 11.95, 95% CI - 0.87 to 24.77; MCS 10.04, 95% CI - 2.78 to 22.86).
This trial could not show a relevant difference in overall morbidity after 24 months of follow-up in favor of elective umbilical hernia repair, because of the limited number of patients included. However, elective repair of umbilical hernia in patients with liver cirrhosis and ascites appears feasible, nudging its implementation into daily practice further, particularly for patients experiencing complaints.
Clinicaltrials.gov , NCT01421550, on 23 August 2011.
确定合并肝硬化和腹水的脐疝患者的最佳治疗方案。
将患有脐疝和肝硬化伴腹水的患者随机分为接受择期修补或保守治疗。主要终点是在 24 个月随访后与脐疝或其治疗相关的总发病率。次要终点包括这些疝相关并发症的严重程度、生活质量和累积疝复发率。
本研究共纳入 34 例患者。16 例患者被随机分配接受择期修补，18 例患者接受保守治疗。24 个月后，与接受择期修补的 16 例患者相比，有 8 例（50%）患者因脐疝或其修补术而出现与脐疝相关的并发症；16.7%接受修补术的患者出现疝复发。次要终点方面，在 12 个月的随访中，通过身体成分评分（PCS）和精神成分评分（MCS）评估的生活质量在两组之间没有显著差异（PCS 平均差异 11.95，95%CI-0.87 至 24.77；MCS 平均差异 10.04，95%CI-2.78 至 22.86）。
由于纳入患者数量有限，本试验在 24 个月的随访后，无法显示择期脐疝修补术在总发病率方面的显著差异。然而，对于肝硬化和腹水患者，择期修补脐疝似乎是可行的，进一步推动其在日常实践中的应用，特别是对有症状的患者。
Clinicaltrials.gov，NCT01421550，于 2011 年 8 月 23 日注册。
