The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- defecation frequency
研究概览
简要总结
Preservation of pelvic autonomic nerves to retain genitourinary function without compromise of oncologic clearance of tumor has been extensively studied in rectal cancer surgery. However, there is still not much information about preservation of autonomic nerves after colectomy for right and left colon cancer. Because the abdominal deep-seated neural structures, such as abdominal plexus (superior hypogastric plexus), neurovascular bundles of SMA, SMV and IMV were within the boundary of dissection, traditional colectomy for right and left colon cancer extended simultaneous dissection of the lateral bundles and entire circle of the neural plexuses surrounding the SMV and IMV. However, a severe and persistent diarrhea, enterospasm, or enteroparalysis developed in almost some patients. It is therefore opinion that during the colectomy for right and left colon cancer, preservation of autonomic nerves may be a priority-that is, autonomic nerve preservation is appropriate unless there are oncologic reasons for the resection of nerves. Therefore, the investigators conducted the present study to test the feasibility of laparoscopic approach in performing the total abdominal autonomic nerve preservation during the standard oncologic resection of right/left colon cancer. The investigators hypothesized that given a well-illuminated magnified view by laparoscopy, the autonomic nerves can be well protected from inadvertent surgical damage. Therefore, the investigators aimed to compare the efficacy and safety of the total abdominal autonomic nerve preservation (TNP) versus traditional CME of right/left colon cancer.
详细描述
This prospective controlled trial was done in FUSCC. Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the descending colon, without evidence of distant metastases. Participants were randomly assigned (1:1) to TNP or CME during laparoscopic right/left colectomy. Abdominal autonomic nerve were dissected in the CME but not in the TNP procedure. Neither investigators nor participants were masked to their group assignment but the quality control committee were masked to group assignment. The primary endpoint was postoperative bowel function recovery, including defecation frequency, diarrhea and enterospasm; The secondary outcomes were 3-year disease-free survival, intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death from any cause within 30 days of surgery), and central lymph node metastasis rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •18-75 years old
- •Pathologically confirmed adenocarcinoma of right side of colon and descending colon.
- •Localization of the tumor ranging from the cecum to the descending colon
- •Tumors clinically staged as T2-4aN0M0 or TanyN + M0, according to imaging studies including enhanced computed tomography (CT) scan, magnetic resonance imaging (MRI), etc.
- •American Society of Anesthesiologists (ASA) score of I, II, or III.
排除标准
- •Synchronous or metachronous multiple primary colorectal cancer
- •Preoperative imaging examination shows enlargement of the central lymph nodes, which mandates a D3 lymphadenectomy
- •Preoperative imaging examination shows that the tumor involves the adjacent organs, requiring combined multiple organ resections, or radical excision (R0 resection) is not possible
- •History of any other malignant tumor in past 5 years, except for cervical carcinoma in situ that has been cured, basal cell carcinoma, or squamous cell carcinoma of skin
- •Patients who need an emergency operation
- •Patients who are not suitable to undergo laparoscopic surgery (due to, e.g., extensive adhesion caused by prior abdominal surgery, inability to endure artificial pneumoperitoneum, etc.).
研究组 & 干预措施
TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer
Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer
干预措施: Abdominal autonomic nerve preserverd in the TNP arm (Procedure)
traditional CME
Abdominal autonomic nerve were dissected in the CME
结局指标
主要结局
defecation frequency
时间窗: one year
defecation frequency
diarrhea
时间窗: 1 year
diarrhea frequency
enterospasm
时间窗: 1 year
enterospasm frequency
次要结局
- oncological outcome(3-year)
研究者
Junjie Peng
Principal Investigator
Fudan University
