The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery: A Multicenter Randomized Controlled Trial (RC09-FIAS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- 3-year stoma-free survival postoperatively
研究概览
简要总结
The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are:
- Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer?
- Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery.
Participants will:
- Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio.
- Receive the corresponding surgical intervention.
- Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery.
- Provide relevant clinical data (perioperative, pathological, follow-up) as required.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;
- •Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;
- •Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm, and without invasion of the external anal sphincter;
- •For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below;
- •Patients underwent radical laparoscopic/robot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).
排除标准
- •Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;
- •History of previous open surgery (non-minimally invasive procedures);
- •Failure to undergo preoperative rectal MRI evaluation and chest/abdominal imaging assessment, resulting in incomplete clinical staging of the tumor;
- •Pregnant patients or those with concurrent inflammatory bowel disease;
- •Preoperative patients with complete intestinal obstruction or requiring emergency surgery;
- •Preoperative evaluation necessitating combined organ resection;
- •Recent treatment for other malignancies;
- •Low rectal cancer classified as type IV in the Bordeaux classification system;
- •Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma.
研究组 & 干预措施
LAR group
First Surgery
- The inferior mesenteric artery is transected at its root.
- After mobilization to the levator ani hiatus, surgeons may choose to transect the intestinal tract using a linear cutting stapler under laparoscopy according to the location of the tumor's lower margin. Subsequently, a circular stapler is inserted transanally to perform sigmoid-colorectal anastomosis or sigmoid-anal canal anastomosis.
- If the tumor is adjacent to the anal canal, an intersphincteric resection (ISR) is required, and hand-sewn end-to-end sigmoid-anal canal anastomosis is completed transanally.
- All patients in the LAR group undergo a protective stoma, which is placed in the right lower quadrant through the rectus abdominis muscle as a loop ileostomy.
Second Surgery The stoma reversal surgery for patients in the LAR group should be completed 3 to 4 months after the first surgery.
干预措施: LAR (Procedure)
TCA group
First Surgery
- Abdominal procedure: The inferior mesenteric artery is ligated at its root. The splenic flexure of the colon is mobilized.
- After mobilization to the levator ani hiatus and entry into the intersphincteric space, the procedure switches to transanal operation. The full thickness of the rectal wall is incised 1 cm above the lower edge of the tumor.
5. The rectal tumor and sigmoid colon are pulled out transanally. The sigmoid colon is transected approximately 8 cm above the tumor to complete tumor resection. The distal sigmoid colon is pulled out 4-5 cm through the anus, and the four pre-placed marking sutures are secured to fix sigmoid colon to the anal canal stump.
Second Surgery
1. The second surgery for resecting the pulled-out intestinal segment is performed 7-11 days after the first operation. The pulled-out intestinal segment is transected approximately 2 mm caudal to the anal canal stump plane. Subsequently, end-to-end anastomosis is completed.
干预措施: Turnbull-Cutait anastomosis (Procedure)
结局指标
主要结局
3-year stoma-free survival postoperatively
时间窗: 3 years
During the follow-up period, death from any cause or an irreducible enterostomy (whichever occurs first) was recorded. An irreducible enterostomy was defined as an event where the enterostomy had not been reduced by the end of the 3-year follow-up period, or at the time of loss to follow-up, or at the time of death.
次要结局
- LARS grading(3 months, 6 months, 9 months, 1 year, 2 years, 3 years)
- Wexner scale(3 months, 6 months, 9 months, 1 year, 2 years, 3 years)
- Quality of Life Questionnaire (EORTC QLQ-CR29)(1 month, 6 months, 1 year)
研究者
Quan Wang
Principal Investigator (PI)
The First Hospital of Jilin University