Uni-center, Patient-blinded, Randomized, 12 Month, Parallel-group, Non-inferiority Study to Compare Outcomes of Three-row Versus Two-row Circular Staplers for Colorectal Anastomosis Formation After Low Anterior Resection for Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Anastomotic leakage rate
研究概览
简要总结
This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.
详细描述
A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler.
A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated consent to comply with all study procedures and availability for the duration of the study
- •Male or female
- •For females of reproductive potential: not pregnant at the time of screening
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- •Histologically proven primary rectal adenocarcinoma located within 5 to 15 cm from anal verge not involving internal and/or external sphincter muscle
- •Non-inclusion Criteria:
- •Current use of antiplatelet drugs, acetylsalicylic acid or anticoagulants within 7 days prior to intervention
- •Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection
- •Inability to save the left colic artery
- •Diameter of rectal lumen is unable to contain the working part of the stapler
- •Infection requiring antibiotic treatment within 30 days prior to intervention
- •Anal incontinence prior to surgery (Wexner Continence Grading Scale >=10)
- •Significant comorbidities - ASA > III
- •Exclusion criteria:
- •Patient lost for observation
- •Inability to complete all the trial procedures
- •Death due to causes unrelated to anastomotic leak in early postoperative period
- •Current smoker or tobacco use within <specify timeframe>
- •Patient wants to withdraw from the clinical trial
排除标准
- 未提供
研究组 & 干预措施
Two-row anastomosis
Colorectal anastomosis is created with a two-row circular surgical stapler
干预措施: Two-row circular stapler (Device)
Three-row anastomosis
Colorectal anastomosis is created with a three-row circular surgical stapler
干预措施: Three-row circular stapler (Device)
结局指标
主要结局
Anastomotic leakage rate
时间窗: 6 weeks
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
次要结局
- Early postoperative complications rate(30 days)
- Circular stapler misfunction rate(1 day)
- The postoperative hospital stay(1 month)
- Complications of defunctioning stoma(3 months)
- Operating time(1 day)
- Anastomotic bleeding rate(30 days)
- Re-intervention rate(6 weeks)
- Manifestation of Low Anterior Resection Syndrome (LARS)(7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery)
- Adverse events rate(12 months)
- Overall quality of life(7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery)
- Serious adverse events rate(12 months)
- Cancer-related quality of life(7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery)
研究者
Inna Tulina
Head of Oncologic Colorectal Surgery Department, Clinic of Colorectal and Minimally Invasive Surgery
I.M. Sechenov First Moscow State Medical University