Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.
Trials. 2020 Jul 2;21(1):608. doi: 10.1186/s13063-020-04507-8.
Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications.
This is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done.
This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure.
ClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.
中腹部切开术后的伤口并发症很常见，是术后发病率的主要来源，包括浅表或深部伤口感染、皮肤裂开、筋膜裂开和切口疝。腹部闭合并发症与缝合技术和材料密切相关，此外还与患者和手术类型等其他因素有关。传统技术是将筋膜缝线相隔 1 厘米，距离筋膜边缘至少 1 厘米。瑞典的一项研究描述了一种新的技术，将缝线相隔 5 毫米，距离筋膜边缘 5 毫米，可降低腹部伤口并发症的发生率。这项研究有许多局限性。需要改进高质量的证据，以使外科界相信改变腹部伤口的闭合技术可以降低发病率，这在切口疝和其他各种术后并发症中得到了体现。
这是一项 1:1 随机、对照、患者和评估者设盲、平行设计的优效性试验，主要终点是 1 年后切口疝。该研究将在 AUBMC 进行，为期 3 年。计划进行普通外科或血管手术的非紧急中腹部切开术的患者将随机分为筋膜闭合技术组。为了检测切口疝发生率降低 12%，在 80%的功效和 0.05 的α值下，我们需要在每个臂招募 114 名患者。在调整随访丢失后，目标招募人数为 274 名受试者。我们将比较两组的主要、次要和探索性结局，使用卡方检验或 t 检验。将进行单变量和多变量逻辑回归分析。
这项试验将通过两种不同的缝合技术评估腹部正中伤口闭合后的术后并发症。这项试验将产生基于证据的结论，使外科医生能够评估一种新的腹部闭合技术在减少常见手术的短期和长期术后并发症方面的作用。
ClinicalTrials.gov NCT03527433. 于 2018 年 5 月 17 日开始入组前注册。
