Nordic Extended Abdominoperineal Excision (NEAPE) Study, a RCT Comparing a Porcine Acellular Dermal Collagen Implant (Biological Mesh) With a Gluteus Maximus Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 16
- 主要终点
- Performance in Timed-Stands Test
研究概览
简要总结
The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are:
- a technique using a gluteus maximus myocutaneous flap or
- a technique using an acellular porcine collagen implant (biological mesh)
The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap.
The study is interventional, randomized and by definition a comparative effectiveness research project.
详细描述
Extended abdominoperineal excision (EAPE) of the rectum is the potentially curative operation for rectal carcinomas too low for primary anastomosis, especially if the levator and sphincter musculature is infiltrated. This enlarged operation, when the levator musculature is excised en bloc with the rectum, creates a large defect. Primary closure is often not possible, and reconstruction with prosthetic material or a myocutaneous flap is necessary to avoid a perineal hernia. Implantation of a collagen sheet (biological mesh) has shown preliminary good results and on the other hand, the use of a gluteus myocutaneous flap is routine in many clinics. There is a lack of scientific evidence to prove which method is better for the reconstruction of the lesser pelvic floor.
The current study aims to compare the two reconstruction techniques.
Centres that treat locally advanced rectal cancers with the extended abdominoperineal excision of rectum (EAPE)[Holm et al 2007] can participate provided that:
- the operative technique is standardized according to the study protocol
- the centre/unit has resources for examinations of participants by a physiotherapist or a nurse
- the centre/unit has one investigator in charge of the study locally
- the centre/unit has an operative volume that enables at least 6 patients to be included/randomised during the anticipated three year study phase for inclusions
Centres that do not operate the rectal cancers included in this study can participate by arranging the preoperative examination and physical tests as well as follow-up of patients that are referred to other centres for the operation. In these cases the operating centre cares for the randomisation, operation and start of postoperative rehabilitation while the study follow-up and final rehabilitation can be completed at the patients' primary referral hospital. The primary referral hospital needs a site investigator in charge of study patients just like centres that do the operations.
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
- 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
- •Adult (18 years or older) rectal cancer patients where wide resection of pelvic floor muscles together with rectum and anal canal have made reconstruction of pelvic floor necessary i.e. primary suture of pelvic floor in the midline is not possible. Resection of coccyx is optional.
排除标准
- •Age less than 18 years
- •Very large resections including partial resection of sacrum and patients considered for bilateral flap reconstruction
- •Large concomitant resection of vaginal wall where total (vaginal) wound closure is not an option
- •Expected survival less than one year at operation
- •Patient do not sign informed consent document
结局指标
主要结局
Performance in Timed-Stands Test
时间窗: 6 months after surgery
Timed-Stands test is a combined measure of physical performance depending on at least muscle strength, balance, tenderness of gluteal skin and muscles and co-ordination of motion.
次要结局
- Quality of life spot measures(3, 6 and 12 months after surgery)
- Local recurrence(Five years after surgery)
- Change of pain and discomfort in gluteal region measured with VAS(3, 6 and 12 months after surgery compared to preoperative)
- Quality-adjusted life years (QALYs gained)(12 months after surgery)
- Ability to sit(3, 6 and 12 months after surgery)
- Costs of surgical treatment(12 months after surgery)
- Change in physical performance(3, 6 and 12 months after surgery compared with preoperative results)
- Primary wound healing assessed with the Southampton Wound Assessment Scale(3 months from operation)
- Complications according to classification by Dindo-Clavien(3, 6 and 12 months after surgery)
- Pain and discomfort in gluteal region, spot measures with VAS(3, 6 and 12 months after surgery)
- Change of quality of life measured with EQ-5D and EORTC forms C30 and CR29(3, 6 and 12 months after surgery compared to preoperative)
- Proportion of persistent perineal sinus or fistula(3, 6 and 12 months after surgery)
- Length of hospital stay(Six months after surgery)