Ferry Philippe, Bertherat Pauline, Gauthier Anne, Villet Richard, Del Piano Francesco, Hamid David, Fernandez Hervé, Broux Pierre-Louis, Salet-Lizée Delphine, Vincens Etienne, Ntshaykolo Pierre, Debodinance Philippe, Pocholle Philippe, Thirouard Yannick, de Tayrac Renaud
La Rochelle Hospital, 17000 La Rochelle, France.
Groupe Hospitalier de la Rochelle Ré Aunis, 17000 La Rochelle, France.
J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):443-449. doi: 10.1016/j.jogoh.2018.06.001. Epub 2018 Jun 18.
Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP).
To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m): Restorelle Direct Fix™.
A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification.
Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V.
This multicentre case-series on the early experience of the use of anterior Restorelle Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle Direct Fix™ mesh performances and to appraise patient satisfaction feedback.
阴道网片的安全信息有限，尤其是关于使用超轻网片的单切口技术治疗盆腔器官前脱垂（POP）。
确定使用超轻网片（19g/m）Restorelle Direct Fix™进行盆腔器官前脱垂修复术后的术中及术后并发症发生率。
回顾性分析2013年1月至2016年12月期间在10个三级和二级护理中心连续接受手术的218例患者的病例系列。符合条件的患者计划进行阴道POP修复（复发或未复发），使用Restorelle Direct Fix™前网片（有或无后网片）。手术并发症采用Clavien-Dindo分类法分级。
术中并发症包括膀胱损伤（0.5%）、直肠损伤（0.5%）、输尿管损伤（0.9%）。98.2%的患者无术中并发症。我们观察到1例手术失败。早期并发症主要包括尿潴留（8.7%）、尿路感染（5.5%）和血肿（2.7%）。1例血肿需要手术治疗，另1例需要栓塞治疗。80.7%的患者在住院期间无并发症，80.3%的患者在随访时无并发症。分析的因素（年龄、体重指数、手术史、脱垂程度或同期手术）均与围手术期并发症风险无显著相关性。根据Clavien Dindo分类，共有2.8%的患者发生III级并发症。无IV级或V级并发症。
这项关于使用Restorelle Direct Fix™前网片早期经验的多中心病例系列显示，其技术可行性令人满意，根据Clavien Dindo分类，III级并发症发生率较低。需要进行长期研究以评估Restorelle Direct Fix™前网片的性能并评估患者满意度反馈。
