Ahmad Gaity, Gent David, Henderson Daniel, O'Flynn Helena, Phillips Kevin, Watson Andrew
Department of Obstetrics and Gynaecology, Pennine Acute Hospitals NHS Trust, Manchester, UK.
Cochrane Database Syst Rev. 2015 Aug 31;8:CD006583. doi: 10.1002/14651858.CD006583.pub4.
Laparoscopy is a common procedure in many surgical specialities. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life-threatening complications include injury to viscera e.g. the bowel or bladder, or to vasculature e.g. major abdominal and anterior abdominal wall vessels. Minor complications can also occur, such as postoperative wound infection, subcutaneous emphysema, and extraperitoneal insufflation. There is no clear consensus as to the optimal method of laparoscopic entry into the peritoneal cavity.
To evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery.
This updated review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group. In addition, MEDLINE, EMBASE, CENTRAL and PsycINFO were searched through to September 2014.
We included randomised controlled trials (RCTs) in which one laparoscopic entry technique was compared with another.
Two authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods.
The review included 46 RCTs including three multi-arm trials (7389 participants) and evaluated 13 laparoscopic entry techniques. Overall there was no evidence of advantage using any single technique for preventing major vascular or visceral complications. The evidence was generally of very low quality; the main limitations were imprecision and poor reporting of study methods. Open-entry versus closed-entry There was no evidence of a difference between the groups for vascular (Peto OR 0.14, 95% CI 0.00 to 6.82, three RCTs, n = 795, I(2) = n/a; very low quality evidence) or visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08, three RCTs, n = 795, I(2) = 0%; very low quality evidence). There was a lower risk of failed entry in the open-entry group (Peto OR 0.16, 95% CI 0.04 to 0.63, n = 665, two RCTs, I(2) = 0%; very low quality evidence). This suggests that for every 1000 patients operated on, 31 patients in the closed-entry group will have failed entry compared to between 1 to 20 patients in the open-entry group. No events were reported in any of the studies for mortality, gas embolism or solid organ injury. Direct trocar versus Veress needle entry There was a lower risk of vascular injury in the direct trocar group (Peto OR 0.13, 95% CI 0.03 to 0.66, five RCTs, n = 1522, I(2) = 0%; low quality evidence) and failed entry (Peto OR 0.21, 95% CI 0.14 to 0.30, seven RCTs, n = 3104; I ²= 0%; moderate quality evidence). This suggests that for every 1000 patients operated on, 8 patients in the Veress needle group will experience vascular injury compared to between 0 to 5 patients in the direct trocar group; and that 64 patients in the Veress needle group will experience failed entry compared to between 10 to 20 patients in the direct trocar group. The vascular injury significance is sensitive to choice of statistical analysis and may be unreliable. There was no evidence of a difference between the groups for visceral (Peto OR 1.02, 95% CI 0.06 to 16.24, four RCTs, n = 1438, I(2) = 49%; very low quality evidence) or solid organ injury (Peto OR 0.16, 95% Cl 0.01 to 2.53, two RCTs, n = 998, I(2) = n/a; very low quality evidence). No events were recorded for mortality or gas embolism. Direct vision entry versus Veress needle entry There was no evidence of a difference between the groups in the rates of visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34, one RCT, n = 194; very low quality evidence). Other primary outcomes were not reported. Direct vision entry versus open-entry There was no evidence of a difference between the groups in the rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50, two RCTs, n = 392; low quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67, one RCT, n = 60, I(2) = n/a; very low quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09, one RCT, n = 60; low quality evidence). Vascular injury was reported, however no events occurred. Our other primary outcomes were not reported. Radially expanding (STEP) trocars versus non-expanding trocars There was no evidence of a difference between the groups for vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21, two RCTs, n = 331, I(2) = 0%; low quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37, two RCTs, n = 331, I(2) = n/a; low quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91, one RCT, n = 244; very low quality evidence). Other primary outcomes were not reported. Comparisons of other laparoscopic entry techniquesThere was a higher risk of failed entry in the group in which the abdominal wall was lifted before Veress needle insertion than in the not-lifted group (Peto OR 4.44, 95% CI 2.16 to 9.13, one RCT, n = 150; very low quality evidence). There was no evidence of a difference between the groups in rates of visceral injury or extraperitoneal insufflation. The studies had small numbers and excluded many patients with previous abdominal surgery, and women with a raised body mass index. These patients may have unusually high complication rates.
AUTHORS' CONCLUSIONS: Overall, there is insufficient evidence to recommend one laparoscopic entry technique over another.An open-entry technique is associated with a reduction in failed entry when compared to a closed-entry technique, with no evidence of a difference in the incidence of visceral or vascular injury.An advantage of direct trocar entry over Veress needle entry was noted for failed entry and vascular injury. The evidence was generally of very low quality with small numbers of participants in most studies; our findings should be interpreted with caution.
腹腔镜检查是许多外科专科常见的手术操作。腹腔镜检查引起的并发症通常与最初进入腹腔有关。危及生命的并发症包括对内脏(如肠道或膀胱)或脉管系统(如腹部主要血管和腹前壁血管)的损伤。也可能发生轻微并发症,如术后伤口感染、皮下气肿和腹膜外充气。关于腹腔镜进入腹腔的最佳方法尚无明确共识。
评估不同腹腔镜进入技术在妇科和非妇科手术中的益处和风险。
本次更新的综述采用了Cochrane月经紊乱与生育力低下小组制定的检索策略。此外,检索了截至2014年9月的MEDLINE、EMBASE、CENTRAL和PsycINFO数据库。
我们纳入了将一种腹腔镜进入技术与另一种技术进行比较的随机对照试验(RCT)。
两位作者独立选择研究、评估偏倚风险并提取数据。我们将研究结果表示为带有95%置信区间(CI)的Peto比值比(Peto OR)。我们使用I²统计量评估统计异质性。我们使用GRADE方法评估主要比较的总体证据质量。
该综述纳入了46项RCT,包括三项多臂试验(7389名参与者),并评估了13种腹腔镜进入技术。总体而言,没有证据表明使用任何单一技术在预防主要血管或内脏并发症方面具有优势。证据质量通常非常低;主要局限性是不精确和研究方法报告不佳。开放入路与闭合入路:两组在血管损伤(Peto OR 0.14,95%CI 0.00至6.82,三项RCT,n = 795,I² = 无数据;极低质量证据)或内脏损伤(Peto OR 0.61,95%CI 0.06至6.08,三项RCT,n = 795,I² = 0%;极低质量证据)方面没有差异的证据。开放入路组进入失败的风险较低(Peto OR 0.16,95%CI 0.04至0.63,n = 665,两项RCT,I² = 0%;极低质量证据)。这表明每1000例接受手术的患者中,闭合入路组有31例进入失败,而开放入路组为1至20例。在任何研究中均未报告死亡、气体栓塞或实体器官损伤事件。直接套管针与Veress针穿刺:直接套管针组血管损伤风险较低(Peto OR 0.13,95%CI 0.03至0.66,五项RCT,n = 1522,I² = 0%;低质量证据)和进入失败风险较低(Peto OR 0.21,95%CI 0.14至0.30,七项RCT,n = 3104;I² = 0%;中等质量证据)。这表明每1000例接受手术的患者中,Veress针组有8例发生血管损伤,而直接套管针组为0至5例;Veress针组有64例进入失败,而直接套管针组为10至20例。血管损伤的意义对统计分析的选择敏感,可能不可靠。两组在内脏损伤(Peto OR 1.02,95%CI 0.06至16.24,四项RCT,n = 1438,I² = 49%;极低质量证据)或实体器官损伤(Peto OR 0.16,95%CI 0.01至2.53,两项RCT,n = 998,I² = 无数据;极低质量证据)方面没有差异的证据。未记录死亡或气体栓塞事件。直视进入与Veress针穿刺:两组在内脏损伤发生率方面没有差异的证据(Peto OR 0.15,95%CI 0.01至2.34,一项RCT,n = 194;极低质量证据)。未报告其他主要结局。直视进入与开放入路:两组在内脏损伤发生率(Peto OR 0.13,95%CI 0.00至6.50,两项RCT,n = 392;低质量证据)、实体器官损伤(Peto OR 6.16,95%CI 0.12至316.67,一项RCT,n = 60,I² = 无数据;极低质量证据)或进入失败(Peto OR 0.40,95%CI 0.04至4.09,一项RCT,n = 60;低质量证据)方面没有差异的证据。报告了血管损伤,但未发生事件。未报告我们的其他主要结局。径向扩张(STEP)套管针与非扩张套管针:两组在血管损伤(Peto OR 0.24,95%CI 0.05至1.21,两项RCT,n = 331,I² = 0%;低质量证据)、内脏损伤(Peto OR 0.13,95%CI 0.00至6.37,两项RCT,n = 331,I² = 无数据;低质量证据)或实体器官损伤(Peto OR 1.05,95%CI 0.07至16.91,一项RCT,n = 244;极低质量证据)方面没有差异的证据。未报告其他主要结局。其他腹腔镜进入技术的比较:在Veress针插入前提起腹壁的组比未提起的组进入失败风险更高(Peto OR 4.44,95%CI 2.16至9.13,一项RCT,n = 150;极低质量证据)。两组在内脏损伤或腹膜外充气发生率方面没有差异的证据。这些研究样本量小,排除了许多既往有腹部手术史的患者以及体重指数升高的女性。这些患者可能并发症发生率异常高。
总体而言,没有足够的证据推荐一种腹腔镜进入技术优于另一种。与闭合入路技术相比,开放入路技术与进入失败率降低相关,在内脏或血管损伤发生率方面没有差异的证据。直接套管针进入在进入失败和血管损伤方面优于Veress针进入。证据质量通常非常低,大多数研究参与者数量少;我们的研究结果应谨慎解释。