Department for Visceral, Thoracic and Vascular Surgery, City Hospital Triemli, Zurich, Switzerland.
Colorectal Dis. 2013 Apr;15(4):e186-9. doi: 10.1111/codi.12118.
Circular stapled mucosectomy is the standard therapy for the treatment of symptomatic third-degree haemorrhoids and mucosal prolapse. Recently, new staplers made in China have entered the market offering an alternative to the PPH stapling devices. The aim of this prospective randomized study was to compare the safety and efficacy of these new devices.
Fifty patients with symptomatic third-degree haemorrhoids were randomized to mucosectomy either by using stapler A (CPH32; Frankenman International Ltd, Hong Kong, China; n = 25) or stapler B (PPH03; Ethicon Endo-Surgery, Spreitenbach, Switzerland; n = 25). All procedures were performed by two experienced surgeons. After the stapler was fired by one surgeon, the other surgeon, who was blinded for stapler type, evaluated the stapler line. Postoperative outcome including pain, complications and patient satisfaction were analysed.
Demographic and clinical features were no different between the groups. There was no significant difference regarding venous bleeding (P = 0.55), but arterial bleeding was significantly more frequent when stapler B was used (P < 0.001). This led to significantly more suture ligations (P = 0.002). However, no differences regarding operation time (P = 0.99), weight of the resected mucosa (P = 0.81) and height of the stapler line (anterior, P = 0.18; posterior, P = 0.65) were detected. Postoperative pain scores (visual analogue scale) and patient satisfaction were no different either (P = 0.91 and P = 0.78, respectively). No recurrence or incontinence occurred during follow-up.
CPH32 required significantly fewer sutures for bleeding control along the stapler line after circular mucosectomy. However, operation time, rate of postoperative complications and patient satisfaction were similar in both groups.
环形吻合器黏膜切除术是治疗症状性三度痔和黏膜脱垂的标准疗法。最近，中国制造的新型吻合器进入市场，为 PPH 吻合器设备提供了替代方案。本前瞻性随机研究旨在比较这些新设备的安全性和有效性。
50 例症状性三度痔患者随机分为吻合器 A（CPH32；中国香港 Frankenman 国际有限公司；n=25）或吻合器 B（PPH03；瑞士 Ethicon Endo-Surgery，Spreitenbach；n=25）黏膜切除术组。所有手术均由两位经验丰富的外科医生进行。一位外科医生完成吻合器击发后，另一位对吻合器类型不知情的外科医生评估吻合器线。分析术后结果，包括疼痛、并发症和患者满意度。
两组患者的人口统计学和临床特征无差异。静脉出血无显著差异（P=0.55），但使用吻合器 B 时动脉出血明显更频繁（P<0.001），导致需要更多的缝合结扎（P=0.002）。然而，手术时间（P=0.99）、切除黏膜的重量（P=0.81）和吻合器线的高度（前位，P=0.18；后位，P=0.65）无差异。术后疼痛评分（视觉模拟评分）和患者满意度也无差异（P=0.91 和 P=0.78）。随访期间无复发或失禁。
CPH32 环形黏膜切除术后，沿吻合器线控制出血需要的缝线明显减少。然而，两组的手术时间、术后并发症发生率和患者满意度相似。
