Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 22
- 主要终点
- Number of Patients With Adhesions to Uterine Scars
研究概览
简要总结
The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.
详细描述
This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.
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The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.
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The secondary end points were the assessment, throughout a 3 years follow-up period, of:
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pregnancy rate,
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adverse events related to adhesions,
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adnexal adhesions according to American Fertility Society score,
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abdomino-pelvic adhesions according to the modified American Fertility Society score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
- •Size: diameter ≥ 6 cm at echographia (for the highest diameter)
- •Location interstitial and / or subserosa
- •planned laparotomic surgery
- •negative pregnancy test within 48 hours of surgery
- •signed inform consent
排除标准
- •History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)
- •Pre-operative embolization
- •Endometriosis stage >1 (American Fertility Society classification ≥ 5)
- •Pregnant patient
- •Chronic corticotherapy / immuno-supressor or immuno-modulator drugs
- •Previous analog LH-RH drug therapy for the uterine myoma
结局指标
主要结局
Number of Patients With Adhesions to Uterine Scars
时间窗: 10 to 20 weeks post surgery
The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand.
次要结局
- Fertility(3 years)
- mAFS Abdominopelvic Adhesion Score(10 to 20 weeks post surgery)
- Adnexal Adhesions(10 to 20 weeks post surgery)