Colectomy Reconstruction for Ulcerative Colitis In Sweden and England: a Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy in Patients With Ulcerative Colitis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Patient satisfaction
研究概览
简要总结
Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves.
Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis.
Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Ulcerative colitis (UC) aged between 18 and 60
- •Scheduled for or have previously undergone subtotal colectomy and ileostomy.
- •Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical Mezalasin only.
排除标准
- •Rectal inflammation of Mayo Score >1
- •Poor sphincter function, perianal disease
- •Uncertainty regarding UC diagnosis P
- •Previous colorectal cancer or severe dysplasia
- •Primary Sclerosing Colitis diagnosis
- •>2 year since subtotal colectomy
研究组 & 干预措施
IPAA CRUISE
Patients eligible for both operations choosing ileal pouch anal anastomosis.
干预措施: Ileal pouch anal anastomosis (IPAA) (Procedure)
IRA CRUISE
Patients eligible for both operations choosing ileorectal anastomosis.
干预措施: Ileorectal anastomosis (IRA) (Procedure)
IRA Control
Patients only eligible for ileorectal anastomosis.
干预措施: Ileorectal anastomosis (IRA) (Procedure)
IPAA Control
Patients only eligible for ileal pouch anal anastomosis.
干预措施: Ileal pouch anal anastomosis (IPAA) (Procedure)
Ileostomy Control
Patients who decline reconstruction.
干预措施: ileostomy (Procedure)
结局指标
主要结局
Patient satisfaction
时间窗: 5 years
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
时间窗: 2months
yes/no question if the patient is satisfied with his/her choice of operation
Patient satisfaction
时间窗: 1year
yes/no question if the patient is satisfied with his/her choice of operation
次要结局
- SF-36(short form-36 item)(5 years)
- Female Sexual Function Index-6 (FSFI-6)(5 years)
- International Index of Erectile Function-5 (IIEF-5)(5 years)
- Shor health scale (SHS)(5 years)
- Öresland Score(5 years)
- failure(5 years)
- reoperations(5 years)
- reoperations(1 year)
- reoperations(2 years)
- Shor health scale (SHS)(2 years)
- SF-36(short form-36 item)(2 months)
- SF-36(short form-36 item)(6 months)
- SF-36(short form-36 item)(1 year)
- SF-36(short form-36 item)(2 years)
- Female Sexual Function Index-6 (FSFI-6)(2months)
- Female Sexual Function Index-6 (FSFI-6)(6months)
- Female Sexual Function Index-6 (FSFI-6)(1 year)
- Female Sexual Function Index-6 (FSFI-6)(2 years)
- International Index of Erectile Function-5 (IIEF-5)(2 months)
- International Index of Erectile Function-5 (IIEF-5)(6 months)
- International Index of Erectile Function-5 (IIEF-5)(1 year)
- International Index of Erectile Function-5 (IIEF-5)(2 years)
- Shor health scale (SHS)(2 months)
- Shor health scale (SHS)(6 months)
- Shor health scale (SHS)(1 year)
- Öresland Score(2 months)
- Öresland Score(6 months)
- Öresland Score(1 year)
- Öresland Score(2 years)
- failure(2 months)
- failure(6 months)
- failure(1 year)
- failure(2 years)
- reoperations(2 months)
- reoperations(6 months)
研究者
Anton Risto
Principal investigator
Linkoeping University