NCT04779125已完成不适用
Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
详细描述
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curative intent abdominoperineal resection and permanent colostomy
排除标准
- •Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
- •Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)
- •Diabetes with 1 or more organ damage
- •Dialysis treatment
- •Hepatic cirrhosis Child-Bugh B-C
- •Potentially curable resection not possible
- •Patient undergoing emergency procedures
- •Metastatic disease
- •Vaginal resection, pelvic exenteration and sacrum resection
- •Vaginal perforation
- •Pelvic abscess or perforated tumor
- •Pregnant or suspected pregnancy
结局指标
主要结局
Complications
时间窗: 30 days
Comprehensive complication index
次要结局
- Reoperation rate(30 days)
- Surgical site infections(30 days)
- Operative time(30 days)
- Length of hospital stay(30 days)
- Costs of treatment materials(30 days)
- Total perineal healing time(1 year)
- Perineal fistula(30 days)
- Perineal hernia(12 months)
- Gluteus muscle function measured by time stands test(12 months)
研究者
Elisa Mäkäräinen
Principal Investigator
University of Oulu
研究点 (1)
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