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Statistical Analysis Plan (SAP): What is it and how to develop it? 统计分析计划 (SAP):什么是统计分析计划?
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.07.007
Marc Fradera , Xavier Serra-Aracil
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引用次数: 0
Short-term results of unroofing and marsupialization compared to the Karydakis technique in the treatment of pilonidal sinus. A randomized prospective study 在治疗朝天鼻窦时,与 Karydakis 技术相比,屋顶切开术和臼齿化术的短期效果如何?随机前瞻性研究。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.10.002
Pedro Antonio Parra Baños , Nuria Martínez Sanz , Francisco Miguel González Valverde , Jorge Alejandro Benavides Buleje , Miguel Ruiz Marín , Emilio Peña Ros , Carmen Martínez Sanz , Mari Fe Candel Arenas

Introduction

The treatment of pilonidal sinus (PS) is usually surgical, but no procedure is considered the gold standard. The Karydakis (K) technique is widely used, and unroofing and marsupialization (UM) is a simple surgery with good results.

Primary objective

To evaluate early postoperative complications (EPC) 30 days after UM surgery compared to the K technique.

Secondary objectives

To evaluate surgical time, postoperative pain, patient satisfaction, return to daily activity and early recurrence within 3 months.

Method

Prospective, single-center, randomized study in patients who underwent surgery for primary PS with no abscess between June 2016 and November 2017. They were randomized using a computer-generated block method. To analyze the main objective, a non-inferiority analysis was performed.

Results

122 patients with symptomatic primary PS were randomized: 60 in the K group and 62 in the UM group. Both groups were homogeneous.
There were statistically significant differences between surgery and postoperative complications at 15 and 30 days in favor of UM. There were also differences in favor of UM in surgical time and return to daily activity. During the 90-day follow-up, there were 3 recurrences in the UM group and 0 in the K group.

Conclusions

UM is a simple, minimally invasive, easily reproducible technique that has a lower rate of early complications, with a shorter operative time and an earlier return to daily activity.
导言:治疗朝天鼻窦(PS)的方法通常是手术,但没有一种方法被认为是金标准。Karydakis(K)技术被广泛使用,而UM(Unroofing and marsupialization)是一种简单的手术,效果良好:与 K 技术相比,评估 UM 手术后 30 天的早期术后并发症(EPC):次要目标:评估手术时间、术后疼痛、患者满意度、恢复日常活动情况以及3个月内的早期复发情况:前瞻性、单中心、随机研究,对象为2016年6月至2017年11月期间接受手术治疗的无脓肿原发性PS患者。采用计算机生成区组的方法对他们进行随机分组。为分析主要目标,进行了非劣效性分析:122名无症状原发性PS患者被随机分组:K组60人,UM组62人。两组患者病情相同。手术和术后 15 天和 30 天并发症之间的差异有统计学意义,UM 更优。在手术时间和恢复日常活动方面,UM 也更胜一筹。在 90 天的随访中,UM 组有 3 例复发,K 组为 0 例:UM是一种简单、微创、易于重复的技术,其早期并发症发生率较低,手术时间较短,恢复日常活动的时间较早。
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引用次数: 0
Diathermy versus scalpel in midline abdominal incision: A systematic review and meta-analysis of randomized controlled trials 腹部中线切开术中的热疗与手术刀:随机对照试验的系统回顾和元分析》。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.09.002
Nicole dos Santos Pimenta , Ana Clara Felix de Farias Santos , João Pedro Costa Esteves Almuinha Salles , Juliana Millani de Oliveira , Pedro Henrique Costa Matos da Silva , Renan Carlo Colombari

Introduction

Our study aimed to compare the midline abdominal incision with scalpel and diathermy.

Methods

PubMed, EMBASE, and Cochrane were searched through January 2024 following PRISMA guidelines (PROSPERO, ID: CRD42024516771), and only randomized controlled trials were included. Heterogeneity was assessed using Cochran's Q test and the I2 heterogeneity index. Statistical analysis was performed using Review Manager 5.4 software.

Results

Six randomized controlled trials were included, from which 469 patients (51.5%) received diathermy incision and 442 patients (48.5%) underwent the scalpel technique. Patients treated with the electrocautery approach had less incision blood loss (MD −17.57 mL; P < .01). No statistically significant differences were found between groups regarding wound infection incidence, incision time, incision area or first-day postoperative pain.

Conclusion

Diathermy use in midline abdominal incision may be advocated as it demonstrated a significant reduction in incision-related blood loss, with no differences in wound infection or early postoperative pain incidences compared to the scalpel.
简介我们的研究旨在比较腹部中线切口与手术刀和电热疗法:按照 PRISMA 指南(PROSPERO,ID:CRD42024516771)检索了 PubMed、EMBASE 和 Cochrane,检索期至 2024 年 1 月,仅纳入了随机对照试验。异质性采用 Cochran's Q 检验和 I2 异质性指数进行评估。使用Review Manager 5.4软件进行统计分析:共纳入了 6 项随机对照试验,其中 469 名患者(51.5%)接受了电热切口术,442 名患者(48.5%)接受了手术刀技术。采用电灼法治疗的患者切口失血量较少(MD -17.57 mL; P 结论:电灼法在中线腹腔镜手术中的应用可减少切口失血量:腹部中线切开术中使用电热疗法可显著减少切口相关失血量,与手术刀相比,伤口感染或术后早期疼痛发生率没有差异,因此值得提倡。
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引用次数: 0
Decision-making concordance in thoracic drain management: is necessary previous experience? 胸腔引流管管理决策的一致性:是否需要先前的经验?
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.09.013
Álvaro Fuentes-Martín , Miriam Suena Doncel , José Soro García , Mauricio Alfredo Loucel Bellino , Itziar Gómez-Salvador , Manuel Carrasco-Moraleja , Ángel Cilleruelo Ramos

Introduction

Proper management of thoracic drainages is essential in the recovery of patients after lung resection. This study evaluates the concordance in decision-making for drain removal depending on the type of drainage system used and the previous experience of the personnel.

Material and methods

Prospective, comparative, and stratified randomization study on interobserver variability between senior specialist doctors and inexperienced healthcare personnel in the removal of thoracic drains in patients undergoing lung resection connected to conventional systems (CS) or digital systems (DS) with continuous recording. The withdrawal criteria were established before the study, and decisions were recorded during three postoperative days.

Results

75 patients were included, 38 CS and 37 DS, with no statistically significant differences in sex distribution, age, intervention performed, presence of pleuropulmonary adhesions, drain time, or post-extraction complications between the groups. The overall concordance in drain removal decisions was moderate (kappa = 0.452), with notable variations in concordance depending on the drainage system used: CS (kappa = 0.188) with an overall agreement rate of 61.7% compared to DS (kappa = 0.716) with an overall agreement rate of 86.4%. Digital systems showed substantial concordance regardless of the operator's experience, with kappa values indicating high concordance on all postoperative days.

Conclusions

The use of digital systems for managing thoracic drains significantly improves concordance in clinical decision-making regardless of the experience level. These findings suggest that adopting digital systems not only optimizes patient safety but also reduces the dependence on highly specialized healthcare professionals.
导言:正确处理胸腔引流管对肺切除术后患者的康复至关重要。本研究评估了引流管移除决策的一致性,这取决于所使用的引流系统类型和工作人员以往的经验:前瞻性、比较性和分层随机研究:资深专科医生和缺乏经验的医护人员在为接受肺切除术的患者拔除连接到传统系统(CS)或带连续记录功能的数字系统(DS)的胸腔引流管时的观察者间差异。研究前制定了撤管标准,并记录了术后三天内的撤管决定:两组患者在性别分布、年龄、干预措施、是否存在胸膜肺粘连、引流时间或拔管后并发症方面均无统计学差异。引流管移除决定的总体一致性为中等(kappa = 0.452),根据所用引流系统的不同,一致性也有明显差异:CS(kappa = 0.188)的总体一致率为61.7%,而DS(kappa = 0.716)的总体一致率为86.4%。无论操作者的经验如何,数字系统都显示出很大的一致性,kappa 值表明术后所有天数的一致性都很高:结论:使用数字系统管理胸腔引流管可显著提高临床决策的一致性,与经验水平无关。这些研究结果表明,采用数字化系统不仅能优化患者安全,还能减少对高度专业化医护人员的依赖。
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引用次数: 0
Evaluation of ChatGPT in surgical research 评估外科研究中的 ChatGPT。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.01.010
Sergi Sanchez-Cordero , Julio Mayol
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引用次数: 0
Minimally invasive approach for colonic gallstone ileus 微创方法治疗结肠胆石性回肠炎。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.09.006
Eugenio Licardie , Andrea Balla , José Antonio López-Ruiz , Salvador Morales-Conde
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引用次数: 0
Laparoscopic vs open approach for acute cholecystitis in octogenarians. A prospective multicenter observational nationwide study 八旬老人急性胆囊炎的腹腔镜手术与开腹手术。一项全国性前瞻性多中心观察研究。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.06.008
N. Lluís , C. Villodre , P. Zapater , M. Cantó , L. Mena , J.M. Ramia , F. Lluís , on behalf of the LUCENTUM Project Collaborative Group

Background

The world population is aging, with octogenarians expected to reach over 400 million by 2050. Acute cholecystitis is a serious complication in the elderly. Age is not a contraindication for emergency cholecystectomy, an option that can both save lives and preserve quality of life.

Methods

The present study aimed to compare open and laparoscopic surgical approaches. Over six months, 38 emergency surgery units enrolled all consecutive octogenarians with acute cholecystitis undergoing cholecystectomy. Postoperative outcomes were compared after propensity score matching analysis.

Results

The study included 212 patients (84 years [81–86], 47.2% women). The open approach was used in 32.1% of patients, and the laparoscopic approach in 67.9%. After propensity score matching, a decrease in hospital stays (open, 8 days [6–13]; laparoscopic, 5 days [4–8]; P < .001), 30-day morbidity (open, 48.5%; laparoscopic, 26.5%; P = .01), and 30-day mortality (open, 13.2%, laparoscopic, 1.5%; P = .02) was found. Among the specific postoperative complications, a decrease in septicemia (open, 14.7%; laparoscopic, 0%; P = .001) was observed.

Conclusions

Laparoscopic approach was used in two out of three octogenarians. After propensity score matching, octogenarians undergoing laparoscopic approach had shorter length of hospital stay, fewer 30-day postoperative complications, fewer episodes of septicemia, and less 30-day mortality than octogenarians undergoing open approach. These findings suggest that the laparoscopic approach may be the preferred choice for octogenarians with acute cholecystitis undergoing cholecystectomy.
背景:世界人口正在老龄化,预计到 2050 年,八旬老人将超过 4 亿。急性胆囊炎是老年人的一种严重并发症。年龄并不是急诊胆囊切除术的禁忌症,这种手术既能挽救生命,又能保证生活质量:本研究旨在比较开腹和腹腔镜手术方法。在 6 个月的时间里,38 家急诊外科单位连续招募了所有患有急性胆囊炎并接受胆囊切除术的八旬老人。经过倾向得分匹配分析后,对术后结果进行了比较:研究共纳入 212 名患者(84 岁 [81-86],47.2% 为女性)。32.1%的患者采用开腹手术,67.9%的患者采用腹腔镜手术。经过倾向评分匹配后,住院时间有所缩短(开腹手术,8 天 [6-13];腹腔镜手术,5 天 [4-8];P 结论:开腹手术和腹腔镜手术的住院时间分别为 8 天和 5 天:三分之二的八旬老人采用了腹腔镜手术。经过倾向评分匹配后,与开腹手术相比,接受腹腔镜手术的八旬老人住院时间更短、术后 30 天并发症更少、脓毒血症发作次数更少、30 天死亡率更低。这些研究结果表明,对于患有急性胆囊炎并接受胆囊切除术的八旬老人来说,腹腔镜方法可能是首选。
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引用次数: 0
Epidemiological profile of women with moderate-risk breast cancer mutations 中度风险乳腺癌突变女性的流行病学概况
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.09.008
Rita Galama , Cátia Ribeiro , João Silva , Joaquim Abreu de Sousa
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引用次数: 0
Match detection analysis on SentiMag® system and standard technique in SLNB of breast cancer 乳腺癌 SLNB 中 SentiMag® 系统与标准技术的匹配检测分析。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.09.012
Cristina Isabel Davó Pérez, Virginia Pellicer Sánchez, Edelmira Soliveres Soliveres, María José Cases Baldó, Arantxa Cabrera Vilanova, Lorena Rodríguez Cazalla, Piotr Kosny, Miguel Ángel Morcillo Rodenas

Introduction

In breast cancer surgery, there are techniques for sentinel lymph node biopsy (SLNB) that do not require Nuclear Medicine, such SentiMag®, which uses ferromagnetic particles. The main purpose of this analysis is to study the degree of concordance in SLNB between SentiMag® and the standard method (Tc99 radiotracer). The secondary objective is to identify factors that impact in sentinel node detection rate and matching detection rate between both probes.

Methods

Observational and retrospective study performed from January to December 2021 focused on patients undergoing breast surgery and SLNB who were injected with both tracers, the ferromagnetic SentiMag® and Tc99 radiotracer. Once the diagnostic accuracy tests were performed, a further evaluation of the detection rate for each probe and the concordance between probes were accomplished. After those results, a deeper analysis of differences in detection rates for each probe and concordance between probes were assessed for various factors: neoadjuvant therapy, BMI, mitotic index, and triple-negative immunohistochemical profile.

Results

The clinical study had a sample size of 70 patients. The overall false-negative rate (FNR) was 4.3%. The detection rate was the same for each technique (85.7%). A total of 106 nodes were biopsied, with a concordance rate of 70.75%. Significant differences were found in concordant nodes according to neoadjuvant therapy (p-value 0.012). For the Ki-67 factor (<20 or ≥20), significant differences were found in detected nodes (p-value 0.031 gamma probe; p-value 0.124 SentiMag®).

Conclusions

The detection rates of SentiMag® and the gamma probe are equivalent. The application of the dual technique minimizes the FNR. A high mitotic index affects the detection rate of the gamma probe, and neoadjuvant therapy negatively impacts the concordance rate.
引言在乳腺癌手术中,有一些无需核医学的前哨淋巴结活检(SLNB)技术,如使用铁磁粒子的 SentiMag ®。这项分析的主要目的是研究 SentiMag ® 和标准方法(Tc99 放射性示踪剂)在 SLNB 中的一致性程度。次要目的是确定影响前哨节点检测率和两种探针匹配检测率的因素:方法:2021 年 1 月至 12 月期间进行的观察性和回顾性研究主要针对接受乳腺手术和 SLNB 的患者,他们同时接受了铁磁性 SentiMag ® 和 Tc99 放射性示踪剂两种示踪剂的注射。诊断准确性测试完成后,将进一步评估每个探针的检出率和探针之间的一致性。结果:临床研究的样本量为 70 例患者。总体假阴性率(FNR)为 4.3%。每种技术的检出率相同(85.7%)。共对 106 个结节进行了活检,吻合率为 70.75%。根据新辅助治疗的不同,吻合的结节有显著差异(P 值为 0.012)。对于 Ki-67 因子(结论:SentiMatrix 的检出率与 Ki-67 因子的检出率存在显著差异:SentiMag®和伽马探针的检测率相当。双重技术的应用最大程度地降低了FNR。有丝分裂指数过高会影响伽马探针的检出率,而新辅助治疗会对吻合率产生负面影响。
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引用次数: 0
Post-traumatic pseudoaneurysm of the aortic arch due to esophageal perforation by a fishbone 鱼刺造成食道穿孔,导致主动脉弓创伤后假性动脉瘤。
Pub Date : 2025-01-01 DOI: 10.1016/j.cireng.2024.06.005
Benjamin Thorpe Plaza , Lucía Lesquereux , Ana Berta Bermudez Naveira , Purificación Parada
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引用次数: 0
期刊
Cirugia espanola
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