Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients.
Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients.
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根治性子宫切除术和盆腔淋巴结清扫术后引流与不引流的随机试验：欧洲癌症研究与治疗组织-妇科癌症小组 (EORTC-GCG) 对 234 名患者进行的研究。
DOI：
10.1016/j.ejca.2007.03.011
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发表时间：
2007
影响因子：
8.4
通讯作者：
I. Vergote
中科院分区：
文献类型：
--
作者：
M. Franchi;J. Trimbos;F. Zanaboni;J. v d Velden;N. Reed;C. Coens;I. Teodorović;I. Vergote
广泛子宫切除术和盆腔淋巴结清扫术后引流以防止术后淋巴囊肿形成和手术并发症，这一点存在争议。为了研究引流的临床意义，登记了253例患者，并将234例患者随机分为两组。一组（n=117）进行了术后引流，另一组（n=117）未插入引流管。双臂省略了手术区腹膜的闭合。主要排除标准为术中失血超过3000 ml或手术结束时持续渗血。在术后1个月和12个月进行临床和超声或CT扫描评估。中位随访时间为13.3个月。两个研究组的术后淋巴囊肿形成或术后并发症发生率无差异。晚期（12个月）症状性淋巴囊肿的发生率为3.4%（引流：5.9%;无引流：0.9%）。Fisher精确检验显示差异p值为0.06。手术时间与术后淋巴囊肿的发生有关。得出的结论是，对于手术期间没有过度出血或手术结束时没有渗血的患者，在根治性子宫切除术和盆腔淋巴结清扫术后可以安全地省略引流，而无需盆腔再腹膜化。
Drainage, following radical hysterectomy and pelvic lymph node dissection to prevent postoperative lymphocyst formation and surgical morbidity, is controversial. To study the clinical significance of drainage, 253 patients were registered and 234 patients were randomised into two arms. In one arm (n=117) postoperative drainage was performed, in the other arm (n=117) no drains were inserted. In both arms closure of the peritoneum of the operating field was omitted. The main exclusion criteria were blood loss of more than 3000ml during surgery or persistent oozing at the end of the operation. Clinical and ultrasound or CT-scan evaluation was done at one and 12 months postoperatively. The median follow-up amounted to 13.3 months. No difference in the incidence of postoperative lymphocyst formation or postoperative complications was found between the two study arms. The late (12 months) incidence of symptomatic lymphocysts was 3.4% (drains: 5.9%; no drains: 0.9%). The difference showed a p-value of 0.06 in Fisher’s Exact test. The operating time was related to the occurrence of postoperative lymphocyst formation. It was concluded that drains can be safely omitted following radical hysterectomy and pelvic node dissection without pelvic reperitonisation in patients without excessive bleeding during or oozing at the end of surgery.