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使用补片预防造口旁疝的随机对照前瞻性试验

Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia.

作者信息

Serra-Aracil Xavier, Bombardo-Junca Jordi, Moreno-Matias Juan, Darnell Anna, Mora-Lopez Laura, Alcantara-Moral Manuel, Ayguavives-Garnica Isidro, Navarro-Soto Salvador

机构信息

Servei de Cirurgia General i Aparell Digestiu, Corporació Sanitària Parc Taulí, Parc Taulí s/n, 08208 Sabadell, Barcelona, Spain.

出版信息

Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.

Abstract

BACKGROUND

The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate.

OBJECTIVE

To reduce the incidence of PH by implanting a lightweight mesh in the sublay position.

MATERIAL AND METHODS

Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery.

RESULTS

: The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08).

CONCLUSIONS

Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.

摘要

背景

结肠造口术后末端造口旁疝(PH)的发生率可能高达50%。PH的影响范围从不适到危及生命的并发症。修复PH的外科手术操作困难且失败率高。

目的

通过在腹膜前间隙植入轻质补片来降低PH的发生率。

材料与方法

随机、对照、前瞻性研究。患者计划接受永久性乙状结肠造口术以治疗直肠下三分之一段癌,由同一结直肠外科团队进行手术。研究组在腹膜前间隙植入Ultrapro轻质补片。采用简单随机化方法,估计每组所需样本量为27例。术后1个月及之后每6个月,由对研究目的不知情的独立临床医生和放射科医生对患者进行临床和腹部计算机断层扫描放射学随访。

结果

两组在临床和人口统计学特征方面具有同质性。两组的手术时间和术后发病率相似。死亡率为0。未报告补片不耐受情况。在临床随访中(中位数:29个月,范围:13 - 49个月),对照组记录到11/27(40.7%)例疝,而研究组为4/27(14.8%)例(P = 0.03)。腹部计算机断层扫描显示对照组有14/27(44.4%)例疝,研究组为6/27(22.2%)例(P = 0.08)。

结论

造口旁放置补片可减少PH的出现。该技术安全、耐受性良好且不增加发病率。

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