在沙特阿拉伯利雅得的阿卜杜勒-阿齐兹国王医疗城进行的一项随机对照试验:剖宫产术中皮下和短皮闭合技术的比较

Hanan M Al-kadri, E. Elsherif, L. Khan, Haitham Magdie Fillimban, Saad Kurdi, A. Fayed., Shoeb Qureshi, Saudi Arabia King Abdulaziz Medical City
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摘要

本研究的目的是比较不同缝合技术(皮下缝合与吻合器)对剖宫产术后患者满意度和手术并发症的影响。设计为前瞻性随机对照试验。本研究的背景是沙特阿拉伯利雅得阿卜杜勒·阿齐兹国王医疗城的妇产科。人群或样本包括所有计划择期剖腹产(CS)的孕妇,以消除混杂因素的影响,如由于CS的急迫性导致的伤口并发症。我们计算出所需的样本量为240例患者。因此,为了让我们拒绝原假设,每组需要120名受试者。两组的概率相等(幂)为80%。与该检验相关的I型误差(α)的概率计算为0.05。进行基于计算机的随机化,生成的数字被编码以代表两种不同的皮肤闭合技术。主要观察指标为创面并发症(主要是感染和创面裂开)、术后疼痛、镇痛需求和术后住院时间。次要结局指标为患者满意度评分。两种皮肤缝合方法在短期和长期患者满意度方面具有可比性,但表皮下缝合的伤口并发症发生率较高(OR = 2.41;95% ci: 1.17 4.98;P = 0.02)。总之,两种皮肤缝合方法在短期和长期患者满意度方面是相当的,尽管表皮下缝合的伤口并发症发生率较高。然而,这一发现可能与妊娠人群中糖尿病和高BMI发生率的增加有关,也与实施手术的外科医生的相关经验有关。
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A comparison of subcuticular and staple skin closure techniques for Caesarian Section: A randomized controlled trial in King Abdul-Aziz Medical City, Riyadh, Saudi Arabiaa
The objective of the study is to compare the outcome of different closure techniques (subcuticular suture vs. stapler) on patient satisfaction and operative complications post cesarean section. The design is prospective randomized controlled trial. The setting of this study is the Department of Obstetrics and Gynecology, King Abdul Aziz Medical City, Riyadh, KSA. The population or sample includes all pregnant patients with planned elective Caesarian section (CS) to eliminate the effect of confounders such as wound complications resulting from the emergency nature of CS. We calculated our required sample size to be 240 patients. Consequently, 120 subjects were required in each group in order for us to reject the null hypothesis. Both groups were equal with a probability (power) of 80%. The probability of a Type I error (α) associated with this test was calculated as 0.05. Computer-based randomization was performed and the numbers generated were coded to represent the two-different skin closure techniques. Primary outcome measures were wound complications, mainly infection and wound dehiscence, postoperative pain, analgesia requirement and the length of postoperative hospital stay. The secondary outcome measure was patient satisfaction score. Both methods of skin closure were comparable in terms of shortand long-term patient satisfaction although the incidence of wound complication was higher with subcuticular stitches (OR = 2.41; 95% CI: 1.17 4.98; p = 0.02). In conclusion, both methods of skin closure were comparable in terms of shortand long-term patient satisfaction although the incidence of wound complication was higher with subcuticular stitches. However, this finding could relate to the increased incidence of diabetes and high BMI in our pregnant population, as well as the relative experience of the operative surgeon performing the procedure.
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