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腹腔镜结肠切除术与开放手术:一项对310例未经筛选病例的前瞻性非随机研究。

Laparoscopic colonic resections versus open surgery: a prospective non-randomized study on 310 unselected cases.

作者信息

Lezoche E, Feliciotti F, Paganini A M, Guerrieri M, Campagnacci R, De Sanctis A

机构信息

Department of Patologia Chirurgica, University of Ancona, Ospedale Umberto I, Italy.

出版信息

Hepatogastroenterology. 2000 May-Jun;47(33):697-708.

PMID:10919014
Abstract

BACKGROUND/AIMS: Laparoscopic colorectal surgery, particularly for malignancy, is still debated. The aim of this study was to prospectively evaluate the postoperative outcome as well as the short- and medium-term results of laparoscopic surgery compared with those after open conventional surgery.

METHODOLOGY

A series of 310 consecutive patients, operated on by the same surgical team, have been included in this study; 150 patients (75% with malignant lesions) underwent laparoscopic surgery, whereas 160 patients (73% with malignant lesions) were treated by open surgery. The treatment modality was selected by the patients after reading the informed consent form.

RESULTS

Laparoscopic surgery was technically feasible in 91.4% of cases. Mean operative time for laparoscopic surgery was longer than for open surgery (251 vs. 175 min) (P < 0.001). Mean postoperative hospital stay after laparoscopic surgery was 10.5 days, as compared to 13.3 days after open surgery (P < 0.05). In the laparoscopic surgery group minor complications' rate was 3.6% and compared favorably to the 7.5% observed after open surgery (P = 0.261). No statistically significant difference was observed in the major complications rate (9.4% after laparoscopic surgery and 6.8% after open surgery) and in operative mortality (1.4% for laparoscopic surgery and 0.6% for open surgery). The local recurrence rate was lower after laparoscopic surgery as compared to open surgery: 3% versus 9.2% (P = 0.152), respectively. Mean follow-up was 34.2 months during which time we observed 2 cases of port site recurrence. After implementing adequate prophylactic measures, no parietal implants were observed in the last 80 patients who underwent laparoscopic surgery for malignancy. Distant site metastases occurred in 11% in both groups. At 36 months cumulative survival probability in laparoscopic surgery completed malignant cases was 0.74% as compared to 0.66% after open surgery.

CONCLUSIONS

Morbidity and mortality were similar in the 2 groups. Laparoscopic patients experienced less pain. A slightly higher incidence of local recurrence was observed in the open surgery group, whereas the percentage of distant site metastases and the cumulative survival probability in the 2 groups were similar. Port site recurrences are a cause of concern but they can be prevented with adequate prophylactic measures. The short- and medium-term results of laparoscopic surgery compared favorably with those of open surgery in this prospective non-randomized study. Long-term oncological result are not known yet. In patients with malignancy prospective randomized trials on larger patient numbers are required.

摘要

背景/目的:腹腔镜结直肠手术,尤其是针对恶性肿瘤的手术,仍存在争议。本研究的目的是前瞻性评估腹腔镜手术与开放传统手术后的术后结局以及短期和中期结果。

方法

本研究纳入了由同一手术团队连续进行手术的310例患者;150例患者(75%患有恶性病变)接受了腹腔镜手术,而160例患者(73%患有恶性病变)接受了开放手术。治疗方式由患者在阅读知情同意书后选择。

结果

91.4%的病例中腹腔镜手术在技术上是可行的。腹腔镜手术的平均手术时间比开放手术长(251分钟对175分钟)(P<0.001)。腹腔镜手术后的平均住院时间为10.5天,而开放手术后为13.3天(P<0.05)。腹腔镜手术组的轻微并发症发生率为3.6%,优于开放手术后观察到的7.5%(P=0.261)。在主要并发症发生率(腹腔镜手术后为9.4%,开放手术后为6.8%)和手术死亡率(腹腔镜手术为1.4%,开放手术为0.6%)方面未观察到统计学上的显著差异。与开放手术相比,腹腔镜手术后的局部复发率较低:分别为3%和9.2%(P=0.152)。平均随访时间为34.2个月,在此期间我们观察到2例切口部位复发。在对最后80例接受腹腔镜恶性肿瘤手术的患者采取适当的预防措施后,未观察到腹壁种植转移。两组远处转移发生率均为11%。在腹腔镜手术完成的恶性病例中,36个月时的累积生存概率为0.74%,而开放手术后为0.66%。

结论

两组的发病率和死亡率相似。腹腔镜手术患者疼痛较轻。开放手术组观察到局部复发发生率略高,而两组的远处转移百分比和累积生存概率相似。切口部位复发令人担忧,但可通过适当的预防措施加以预防。在这项前瞻性非随机研究中,腹腔镜手术的短期和中期结果优于开放手术。长期肿瘤学结果尚不清楚。对于恶性肿瘤患者,需要进行更大样本量的前瞻性随机试验。

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