A Single-Center, Prospective, Randomized Clinical Trial Investigating the Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy With Ileal Conduit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit.
研究概览
简要总结
Impact of Manual Versus Mechanical Intestinal Suturing on the Incidence and Management of Postoperative Complications in Patients Undergoing Radical Cystectomy with Ileal Conduit.
详细描述
Currently, no specific trial compares hand-sewn intestinal anastomosis with mechanical stapled anastomosis in patients undergoing radical cystectomy with ileal conduit.
At Fundació Puigvert, approximately one hundred radical cystectomies with ileal conduit are performed annually. Due to the lack of evidence regarding the superiority of either intestinal anastomosis technique, the decision to use hand-sewn versus stapled anastomosis depends on the surgeon's expertise, without considering the potential impact of each technique on postoperative complication rates, surgical time, or functional outcomes.
Currently, no well-designed surgical trials demonstrate differences between hand-sewn and mechanical stapled anastomosis in radical cystectomy regarding intraoperative and postoperative complications. For this reason, the investigators will conduct a trial to assess the impact of each anastomosis technique
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 (Participant)
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
- •Patient who consents to participate and signs the informed consent.
- •Patient candidate for radical open cystectomy and ileal conduit.
排除标准
- •Patient who is unable to complete the study questionnaires.
- •Patient who has a life expectancy of less than 1 year.
- •Candidate patients for other urinary diversions other than ileal conduit as a first option
- •Candidate patients for laparoscopic or robotic cystectomy..
研究组 & 干预措施
Mechanical anastamosis
Intestinal anastamosis will be performed using stapling device
干预措施: cystectomy with ileal conduit, using mechanical bowel anastomosis (Procedure)
Manual anastamosis
Intestinal anastamosis will be performed manually
干预措施: cystectomy with ileal conduit, using manual bowel anastomosis (Procedure)
结局指标
主要结局
Demonstrate the superiority of manual intestinal suturing versus mechanical suturing, defined as a lower incidence of postoperative digestive complications in patients undergoing radical cystectomy with ileal conduit.
时间窗: 1 year
Compare the incidence of gastrointestinal complications according to the type of suturing used in the creation of the ileo-ileal anastomosis in patients undergoing radical cystectomy with ileal conduit during the hospital admission period and at one-year follow-up.
次要结局
- To evaluate the predictive factors of postoperative complications.(1 year)
研究者
Pavel Gavrilov
Consultant surgeon
Fundacio Puigvert