Modified Single-Stapled Anastomosis in Laparoscopic or Robotic Low Anterior Resection for Rectal Cancer: The SMART Trial (Single-Modified Anastomosis for Rectal Cancer Surgery Technique), A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Anastomotic leakage
研究概览
简要总结
The goal of this clinical trial is to learn whether a modified single-stapled anastomosis (MST) can reduce anastomotic leakage compared with the conventional double-stapled technique (DST) in adult patients undergoing laparoscopic or robotic low anterior resection for rectal cancer.
The main questions it aims to answer are:
- Does MST lower the incidence of anastomotic leakage after rectal cancer surgery?
- Does MST improve short-term surgical outcomes compared with DST?
Researchers will compare the MST group with the DST group to see if MST leads to fewer anastomotic leaks and safer postoperative recovery.
Participants will:
Receive either MST or DST during minimally invasive rectal cancer surgery Undergo routine postoperative CT scans within one month after surgery to check for symptomatic or asymptomatic anastomotic leakage Attend scheduled follow-up visits and standard postoperative assessments as part of routine rectal cancer care
详细描述
Anastomotic leakage is one of the most serious complications after low anterior resection (LAR) for rectal cancer. This complication can lead to infection, reoperation, prolonged hospitalization, higher medical costs, and worse long-term oncologic outcomes. Although laparoscopic and robotic surgery have improved short-term recovery compared with open surgery, the risk of anastomotic leakage remains a major concern.
The most commonly used reconstruction method during minimally invasive LAR is the double-stapled technique (DST). In DST, the rectum is transected with a linear stapler and then reconnected with a circular stapler. This creates an intersection between two staple lines, a known weak point that may be prone to leakage due to structural and ischemic vulnerability.
The modified single-stapled technique (MST) eliminates this intersection. Before applying the circular stapler, the two ends of the linear staple line on the rectal stump are brought together using a simple suture. This results in a single, centered staple line that the circular stapler incorporates completely into the anastomosis. Early studies, including a previous randomized trial, suggest that MST significantly reduces anastomotic leakage compared with DST.
This multicenter randomized controlled trial aims to provide high-quality evidence on the effectiveness of MST in reducing anastomotic leakage in patients undergoing laparoscopic or robotic LAR for rectal cancer. A total of 440 adult patients will be enrolled across multiple high-volume university hospitals in South Korea. Participants will be randomly assigned in a 1:1 ratio to receive MST or DST. Randomization will be stratified by sex, neoadjuvant treatment, and study center.
To ensure consistent surgical quality, all participating colorectal surgeons will complete a pre-trial standardization workshop and submit unedited surgical videos for competency review. All surgical procedures will follow standardized steps, and perioperative care will be based on established Enhanced Recovery After Surgery (ERAS) protocols.
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)
盲法说明
No additional parties.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with rectal cancer who are scheduled to undergo laparoscopic or robotic low anterior resection
- •histologically confirmed rectal adenocarcinoma located within 15cm from anal verge.
- •ECOG performance status of 0 to 2
- •Any clinical stage
排除标准
- •Who have significant comorbidities or history of abdominal surgeries that would preclude a minimally invasive approach
- •Bowel obstruction for perforation requiring emergency surgey
- •Concurrent, or recent treatment for colorectal or other malignancies within the past five years
- •Presence of inflammatory bowel diseases
- •Hereditary colorectal cancer syndrome
研究组 & 干预措施
Modified single-stapled anastomosis technique
Participants assigned to this arm will undergo minimally invasive low anterior resection using the modified single-stapled technique. After rectal resection, the two ends of the linear staple line of stump are approximated toward the center using a barbed suture. The circular stapler spike is introduced through the center of the staple line to ensure complete resection of the linear staple line, eliminating staple-line intersections. The reaminder of the procedure, including total mesorectal excision, follows standard oncologic principles.
干预措施: Modified single-stapled anastomosis technique (Procedure)
Double-stapled anastomosis technique
Participants assigned to this arm will undergo minimally invasive low anterior resection using the conventional double-stapled technique. The rectum is transected with linear stapler, followed by transanal introduction of a circular stapler to create an end-to-end anastomosis. The procedure represents current standard practice for low anterior resection in rectal cancer.
结局指标
主要结局
Anastomotic leakage
时间窗: within 30 days after surgery
Anastomotic leakage will be assessed within 30 days after surgery using clinical evaluation and routine abdominopelvic computed tomography (APCT). Leakage is defined as any defect in the anastomosis that results in communication between the inside of the bowel and the surrounding tissue. Diagnostic criteria include clinical symptoms (such as fever, abdominal pain, or drainage contents), abnormal laboratory findings, or radiologic evidence of leakage on APCT. All leaks will be classified according to the grading system. * Grade A: Leakage requiring no active therapeutic intervention. * Grade B: Leakage requiring non-surgical management, such as antibiotics or percutaneous drainage. * Grade C: Leakage requiring reoperation. Routine postoperative CT for all participants ensures consistent and standardized detection of both symptomatic and asymptomatic leaks.
次要结局
未报告次要终点
研究者
Kim, Jin
Professor
Korea University Anam Hospital