痔病新手术治疗的成本效益：经肛门多普勒引导痔动脉结扎术与黏膜外固定术和环形吻合痔切除术的多中心随机对照试验
Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.
机构信息
*Colorectal Unit, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France †Colorectal Unit, Department of Surgery, Michallon University Hospital, Grenoble, France ‡Colorectal Unit, Department of Surgery, University Hospital of Lille, Lille, France §Department of Proctology, University Hospital of Rennes, Rennes, France ¶Department of Digestive Surgery, Poissy Hospital, Saint-Germain en Laye, France ||Department of Digestive Surgery, Vichy Hospital, Vichy, France **Department of Surgery, University Hospital of Angers, Angers, France ††Unit of Methodology and Biostatistics, University Hospital of Nantes, Nantes, France ‡‡Health economics and health policy research unit, AP-HP Paris, France.
出版信息
Ann Surg. 2016 Nov;264(5):710-716. doi: 10.1097/SLA.0000000000001770.
OBJECTIVE
To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD).
BACKGROUND
DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial.
METHODS
Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year.
RESULTS
At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated.
CONCLUSIONS
DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.
目的
比较痔动脉结扎术（DGHAL）与吻合器痔上黏膜环切术（SH）治疗 II/III 度痔病（HD）的效果。
背景
DGHAL 是治疗症状性 HD 的一种选择，现有研究报告显示其风险有限，疗效满意。DGHAL 从未在大规模多机构随机临床试验中与 SH 进行过比较。
方法
2010 年至 2013 年，393 例 II/III 度 HD 患者在 22 个中心被随机分配至 DGHAL（n = 197）或 SH（n = 196）组。主要终点是 3 个月时（D.90）基于 Clavien-Dindo 手术并发症分级的手术相关发病率。在 1 年时评估总费用、成本效益和临床结局。
结果
在 D.90 时，DGHAL 和 SH 组分别有 47 例（24%）和 50 例（26%）患者发生手术相关不良事件（P = 0.70）。DGHAL 导致更长的平均手术时间（44±16 比 30±14 分钟；P < 0.001）、更轻的疼痛（术后和 2 周时的视觉模拟评分：2.2 比 2.8；1.3 比 1.9；P = 0.03；P = 0.013）和更短的病假（12.3 比 14.8 天；P = 0.045）。在 1 年时，DGHAL 导致更多的残留 III 度 HD（15%比 5%）和更高的再次手术率（8%比 4%）。两种手术的患者满意度均>90%。DGHAL 组 1 年总费用更高[&OV0556;2806（&OV0556;2670；2967）比 &OV0556;2538（&OV0556;2386；2737）]。D.90 的增量成本效益比（ICER）为每避免一次并发症&OV0556;7192。在 1 年时，DGHAL 策略占主导地位。
结论
DGHAL 和 SH 是 II/III 度 HD 的可行选择，手术相关风险无显著差异。尽管 DGHAL 导致术后疼痛更轻，病假更短，但费用更高，手术时间更长，且可能提供了更差的解剖学矫正，提示复发风险增加。
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