生物补片盆底重建在直肠癌腹会阴联合切除术后的应用：多中心随机对照研究（BIOPEX 研究）

Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer: A Multicenter Randomized Controlled Trial (the BIOPEX-study).

机构信息

*Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands †Department of Surgery, Deventer Hospital, Deventer, The Netherlands ‡Department of Surgery, Erasmus Medical Center/Daniel den Hoed, Rotterdam, The Netherlands §Department of Surgery, Gelre Hospital, Apeldoorn, The Netherlands ¶Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands ||Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands **Department of Surgery, IJsselland Hospital, Capelle aan de IJssel, The Netherlands ††Department of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands ‡‡Department of Surgery, St. Laurentius Hospital, Roermond, The Netherlands §§Department of Surgery, School of Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands ¶¶GROW: School of Oncology and Developmental Biology, Maastricht, The Netherlands ||||Department of Surgery, University Hospitals Leicester, Leicester, UK ***Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands †††Department of Surgery, Radboud University Medical Center, Nijmegen, The Netherlands ‡‡‡Clinical Research Unit, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

出版信息

Ann Surg. 2017 Jun;265(6):1074-1081. doi: 10.1097/SLA.0000000000002020.

DOI:10.1097/SLA.0000000000002020

PMID:27768621

Abstract

OBJECTIVE

To determine the effect of biological mesh closure on perineal wound healing after extralevator abdominoperineal resection (eAPR).

BACKGROUND

Perineal wound complications frequently occur after eAPR with preoperative radiotherapy for rectal cancer. Cohort studies have suggested that biological mesh closure of the pelvic floor improves perineal wound healing.

METHODS

Patients were randomly assigned to primary closure (standard arm) or biological mesh closure (intervention arm). A non-cross-linked porcine acellular dermal mesh was sutured to the pelvic floor remnants in the intervention arm, followed by a layered closure of the ischioanal and subcutaneous fat and skin similar to the control intervention. The outcome of the randomization was concealed from the patient and perineal wound assessor. The primary endpoint was the rate of uncomplicated perineal wound healing defined as a Southampton wound score of less than 2 at 30 days postoperatively. Patients were followed for 1 year.

RESULTS

In total, 104 patients were randomly assigned to primary closure (n = 54; 1 dropouts) and biological mesh closure (n = 50; 2 dropouts). Uncomplicated perineal wound healing rate at 30 days was 66% (33/50; 3 not evaluable) after primary closure, which did not significantly differ from 63% (30/48) after biological mesh closure [relative risk 1.056; 95% confidence interval (CI) 0.7854-1.4197; P = 0.7177). Freedom from perineal hernia at 1 year was 73% (95% CI 60.93-85.07) versus 87% (95% CI 77.49-96.51), respectively (P = 0.0316).

CONCLUSIONS

Perineal wound healing after eAPR with preoperative radiotherapy for rectal cancer was not improved when using a biological mesh. A significantly lower 1-year perineal hernia rate after biological mesh closure is a promising secondary finding that needs longer follow-up to determine its clinical relevance.

摘要

目的

确定生物网片缝合对接受术前放疗的直肠癌患者行腹会阴联合切除术后会阴伤口愈合的影响。

背景

接受术前放疗的直肠癌患者行腹会阴联合切除术后，会阴伤口并发症常发生。队列研究表明，盆底生物网片缝合可改善会阴伤口愈合。

方法

患者被随机分配至一期缝合（标准组）或生物网片缝合（干预组）。在干预组中，将非交联猪脱细胞真皮网缝合到盆底残端，然后类似于对照组进行坐骨肛门和皮下脂肪及皮肤的分层缝合。患者和会阴伤口评估者均不知道随机分组的结果。主要终点是术后 30 天无复杂会阴伤口愈合的比例，定义为 Southampton 伤口评分<2 分。患者随访 1 年。

结果

共有 104 例患者被随机分配至一期缝合（n=54；1 例脱落）和生物网片缝合（n=50；2 例脱落）。一期缝合后 30 天无复杂会阴伤口愈合的比例为 66%（33/50；3 例无法评估），与生物网片缝合后的 63%（30/48）相比差异无统计学意义[相对危险度 1.056；95%置信区间（CI）0.7854-1.4197；P=0.7177]。1 年时无会阴疝的比例分别为 73%（95%CI 60.93-85.07）和 87%（95%CI 77.49-96.51），差异有统计学意义（P=0.0316）。