Braun Naama Marcus, Andraos Wael, Bettin Stefan
Obstetrics and Gynecology Department, Ziv Medical Center, Safed, Israel; The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
Obstetrics and Gynecology Department, Catholic Hospital Chain Weser-Egge, Sankt Ansgar Hospital, Höxter, Germany.
Eur J Obstet Gynecol Reprod Biol. 2019 Apr;235:88-92. doi: 10.1016/j.ejogrb.2019.02.013. Epub 2019 Feb 20.
The aim of the study was to assess safety and efficacy of apical support when using the soft-tissue metal fasteners of EndoFast Reliant™ SCP during laparoscopic sacrocolpopexy (LSCP).
This is a single-center, retrospective cohort study including all patients which underwent LSCP between 2015 and 2017. Safety outcome included the procedure and the device related complications. Effectiveness outcomes included the anatomical success of apical repair and the functional results as were obtained from the clinic and from a Quality of life questionnaire (PFDI-20).
Eighty-four patients, 54% with grade III and IV prolapse were included in the study. Uterus was preserved in 68% of patients with uterus. Mean follow-up period for the clinic visit was 4.5 ± 4 months. Short term anatomical success was achieved for 98.8% of the patients. Marked improvement was observed in the related symptoms including urinary incontinence. Three intra-operative complications occurred: 1 case of bladder injury, 1 case of intra-abdominal bleeding, and 1 case of post-operative vaginal bleeding. Later complications included only two patients (2.3%) complained of chronic abdominal pain. There were no cases of mesh erosion or de-novo dyspareunia. The mean follow-up period for the PFDI-20 questionnaire was 15.6 months. 75% of patients had no bulge symptoms at all. Quarter of the patients had some bulge symptoms, bothers them between somewhat to moderately according to the questionnaire grading.
The use of Endofast SCP fasteners for laparoscopic promonto-fixation is a safe and effective surgery. Longer follow-up and larger studies should be performed to establish the results.
本研究旨在评估在腹腔镜骶骨阴道固定术(LSCP)中使用EndoFast Reliant™ SCP软组织金属固定器时顶端支撑的安全性和有效性。
这是一项单中心回顾性队列研究,纳入了2015年至2017年间接受LSCP的所有患者。安全结局包括手术及与器械相关的并发症。有效性结局包括顶端修复的解剖学成功情况以及从临床和生活质量问卷(PFDI-20)获得的功能结果。
84例患者纳入研究,其中54%为III级和IV级脱垂。68%有子宫的患者保留了子宫。临床随访的平均时间为4.5±4个月。98.8%的患者短期内获得了解剖学成功。观察到包括尿失禁在内的相关症状有显著改善。术中发生了3例并发症:1例膀胱损伤、1例腹腔内出血和1例术后阴道出血。后期并发症仅2例患者(2.3%)主诉慢性腹痛。没有网片侵蚀或新发性交困难的病例。PFDI-20问卷的平均随访时间为15.6个月。75%的患者完全没有膨出症状。四分之一的患者有一些膨出症状,根据问卷分级,这些症状对他们的困扰程度为轻度到中度。
使用Endofast SCP固定器进行腹腔镜骶岬固定术是一种安全有效的手术。需要进行更长时间的随访和更大规模的研究来确定结果。