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肥胖女性诊断性腹腔镜检查中直接套管针与Veress针穿刺技术有效性和安全性的随机对照试验

Randomized control trial on effectiveness and safety of direct trocar versus Veress needle entry techniques in obese women during diagnostic laparoscopy.

作者信息

Ikechebelu Joseph I, Eleje George U, Joe-Ikechebelu Ngozi N, Okafor Chidimma Donatus, Okpala Boniface Chukwuneme, Ugwu Emmanuel O, Nwachukwu Cyril Emeka, Okoro Chukwuemeka C, Okam Princeston C

机构信息

Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, P.M.B. 5025, Anambra State, Nigeria.

Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, PMB 5025, Nigeria.

出版信息

Arch Gynecol Obstet. 2021 Sep;304(3):815-822. doi: 10.1007/s00404-020-05957-w. Epub 2021 Jan 8.

DOI:10.1007/s00404-020-05957-w
PMID:33417065
Abstract

PURPOSE

To determine the benefits and safety of direct trocar insertion versus Veress needle technique in obese women undertaking diagnostic laparoscopy procedures.

METHODS

Randomized-controlled trial on 135 obese women undergoing diagnostic laparoscopy and dye test for infertility was conducted. Women were randomly assigned to either direct trocar access (n = 68) or Veress needle access (n = 67) before achieving pneumoperitoneum. The same surgeon executed the laparoscopic techniques with a single-puncture technique. The primary outcome measures included total length of the procedure and incidence of any complications, while the mean laparoscopic entry time, volume of CO required, and total of tries needed to attain successful entry were secondary outcomes. Intention-to-treat principle was applied to analysis.

RESULTS

Women in both groups had similar socio-demographic and clinical characteristics and none were lost to follow-up. The overall length of the procedure was significantly lesser in the direct trocar group compared to the Veress needle group (9.9 ± 6.0 vs 16.7 ± 4.7 min; p < 0.001). No significant differences occurred in other outcomes including mean entry time, volume of CO used, number of attempts for successful entry, and major/minor complications (p > 0.05).

CONCLUSIONS

Direct trocar technique may be an effective alternative to Veress needle for pneumoperitoneum in obese women for diagnostic laparoscopy. It has a comparable rapid laparoscopic entry time but a significantly lower duration of the procedure and shorter exposure to anesthesia. Both methods are equally effective as there was no significant difference in the complications recorded. A greater sample trial may be essential for more corroborative substantiation.

CLINICAL TRIAL REGISTRATION

PACTR201510000999192.

摘要

目的

确定在肥胖女性进行诊断性腹腔镜手术时,直接套管针插入术与韦雷氏针技术相比的益处和安全性。

方法

对135例接受诊断性腹腔镜检查和不孕症染料试验的肥胖女性进行随机对照试验。在建立气腹之前,将女性随机分配至直接套管针入路组(n = 68)或韦雷氏针入路组(n = 67)。同一位外科医生采用单穿刺技术实施腹腔镜技术。主要结局指标包括手术总时长和任何并发症的发生率,而平均腹腔镜进入时间、所需二氧化碳量以及成功进入所需的尝试总数为次要结局指标。采用意向性分析原则。

结果

两组女性的社会人口统计学和临床特征相似,且均无失访情况。与韦雷氏针组相比,直接套管针组的手术总时长显著更短(9.9 ± 6.0 vs 16.7 ± 4.7分钟;p < 0.001)。在其他结局指标方面,包括平均进入时间、所用二氧化碳量、成功进入的尝试次数以及严重/轻微并发症方面,均未出现显著差异(p > 0.05)。

结论

对于肥胖女性进行诊断性腹腔镜检查时,直接套管针技术可能是韦雷氏针建立气腹的有效替代方法。其腹腔镜进入时间相当迅速,但手术持续时间显著更短,麻醉暴露时间也更短。两种方法同样有效,因为记录的并发症无显著差异。更大样本的试验对于更确凿的证实可能至关重要。

临床试验注册号

PACTR201510000999192。

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A multicentric prospective study evaluating the safety and efficacy of Kii Fios First Entry Trocar in laparoscopic bariatric surgery.
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Major and minor complications in Veress needle (VN) and direct trocar insertion (DTI) for laparoscopic closed-entry techniques: an updated systematic review and meta-analysis.Veress 针(VN)和直接套管针插入(DTI)在腹腔镜封闭入路技术中的主要和次要并发症:更新的系统评价和荟萃分析。
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