Reconstruction Techniques and Vascular Approach After Laparoscopic Left Hemicolectomy and Laparoscopic Low Anterior Resection for Rectal Cancer: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Total number of resected lymph nodes
研究概览
简要总结
This is an interventional, controlled and randomized single-center clinical trial with patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
All patients included in the study (study 1) are randomized into two groups (group 1A and group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV) and in the group 1B the surgical technique initially dissects the inferior mesenteric artery.
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
Study hypothesis:
Study 1: the surgical technique that initially dissects the IMV presents a greater number of total resected lymph nodes compared to the technique that initially dissects the IMA.
Study 2: latero-terminal anorectal anastomosis has a better anorectal functional outcome than termino-terminal anorectal anastomosis.
Primary outcome measures:
- Study 1:To compare the total number of resected lymph nodes and the distance to the surgical margins between the two arms (1A and 1B).
- Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). The anorectal function will be assessed by the scores of the validated Colorectal Functional Outcome Questionnaire (COREFO) and the validated scale LARS (Syndrome anterior resection of the rectum).
Secondary outcome measures:
- Study 1: to compare the duration of surgery, bleeding and need for surgical conversion between the two arms (1A and 1B). Another objectives are to compare the incidence of postoperative complications (measured by the Clavien-Dindo classification) and survival.
- Study 2: to compare the quality of life and anorectal functional outcomes at : 6, 12, 18 and 24 months after intervention (or ileostomy closure) between the two arms (2A and 2B). The anorectal function will be assessed by the validated COREFO questionnaire and the LARS scale. The quality of life will be assessed by the validated questionnaire of quality of life: SF-36. Another objective is to compare the incidence of postoperative complications assessed by the Clavien-Dindo classification and the incidence of anastomotic leakage.
详细描述
This is an interventional, controlled and randomized single-center clinical trial with patients diagnosed with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
Methods:
All patients included in the study (study 1) are randomized into two groups (group 1A and group 1B): in the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV) and in the group 1B the surgical technique initially dissects the inferior mesenteric artery.
The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
Study hypothesis:
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
- •Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer.
- •Age ≥ 18 years
- •Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- •Any T, any N, M or any adenoma
- •Attempt to R0 resection
- •Signed informed consent by the patient and by the researcher
- •Quality of Life Questionnaire completed
- •Patients with colorectal cancer that will undergo laparoscopic left hemicolectomy or laparoscopic low anterior resection for rectal cancer with colorectal anastomosis.
- •Age ≥ 18 years
- •Histology proven adenocarcinoma or adenoma with or without chemotherapy or neoadjuvant radiochemotherapy
- •Any T, any N, M or any adenoma
- •Attempt to R0 resection
- •Signed informed consent by the patient and by the researcher
- •Quality of Life Questionnaire completed
排除标准
- •Colorectal tumor with different histology to adenocarcinoma or adenoma
- •History of colorectal cancer surgery different to the local excision
- •Inflammatory bowel disease with pathologic confirmation
- •Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- •Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- •Another synchronous malignancy
- •Emergency Surgery
- •Any patient that medical characteristics present an individual risk raised to be included and complete the study
- •Patients who won't undergo colorectal anastomosis
- •Colorectal tumor with different histology to adenocarcinoma or adenoma
- •History of colorectal cancer surgery different to the local excision
- •Inflammatory bowel disease with pathologic confirmation
- •Patients with psychiatric illness, addiction or disorder with inability to understand informed consent
- •Inability to read or understand any of the languages of the informed consent and questionnaires (Catalan, spanish)
- •Another synchronous malignancy
- •Emergency Surgery
结局指标
主要结局
Total number of resected lymph nodes
时间窗: 1 month
Study 1:To compare the total number of resected lymph nodes between the two arms (1A and 1B).
Anorectal functional outcome at 12 months assessed by COREFO questionnaire
时间窗: 12 months
Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). Assessed by the validated Colorectal Functional Outcome Questionnaire (COREFO)
Anorectal functional outcome at 12 months assessed by LARS scale
时间窗: 12 months
Study 2: to compare the anorectal functional outcome at 12 months after surgery or ileostomy closure between the two arms (2A and 2B). Assessed by the validated scale LARS (Syndrome anterior resection of the rectum).
次要结局
- Postoperative complications(90 days)
- Intraoperative outcomes: surgical bleeding(1 day)
- Quality of life-SF questionnaire(6, 12, 18 and 24 months after surgery)
- Survival(5 years)
- Intraoperative outcomes: surgical conversion(1 day)
- Intraoperative outcomes: duration of surgery(1 day)
- Postoperative complications and anastomotic leakage(90 days after surgery)
- Anorectal functional outcome assessed by LARS scale(6,18 and 24 months after surgery)
- Anorectal functional outcome assessed by COREFO questionnaire(6,18 and 24 months after surgery)
- Distance to surgical margins(1 month)
研究者
Pere Planellas Giné
MD-PhD
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta