A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- The Count of Participants With Surgical Site Infection (SSI)
研究概览
简要总结
This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.
详细描述
This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.
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
The clinical surgeons, outcome assessors, data recorders, and statisticians will all operate independently. Due to the nature of the surgical interventions, the surgeons will not be blinded to treatment allocation. However, the outcomes assessor who assess or analyze the end point will be blinded. The patients will also be blinded to group allocation to reduce the risk of bias. Unblinding will not be performed unless the finalization of the main data analysis or required for patient's safety. After the data analysis, we will have a blinded interpretation of the study results to minimize misleading data interpretation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years;
- •histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
- •clinical stage T1-4a, N0-2, and M0;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •suitable for laparoscopic colectomy;
- •no previous systemic chemotherapy or radiotherapy;
- •willing to provide written informed consent and comply with the research procedures.
排除标准
- •Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
- •Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
- •Patients who need to undergo combined organ resection or robot-assisted colectomy.
- •Patients who are receiving preoperative neoadjuvant therapy.
- •ASA grade ≥ IV and/or ECOG performance status score >
- •Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal);
- •Patients with severe psychiatric illness.
- •Pregnant or lactating women.
- •Patients who have a history of taking hormonal drugs.
- •Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
- •Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.
- •Exit criteria
- •Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
- •Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
- •Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
- •Patients who need combined organ resection as determined by intraoperative exploration.
- •Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.
研究组 & 干预措施
laparoscopic assisted left colectomy (extracorporeal anastomosis group)
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured.
干预措施: laparoscopic assisted left colectomy (extracorporeal anastomosis group) (Procedure)
total laparoscopic left colectomy (intracorporeal anastomosis group)
All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed.
干预措施: total laparoscopic left colectomy (intracorporeal anastomosis group) (Procedure)
结局指标
主要结局
The Count of Participants With Surgical Site Infection (SSI)
时间窗: one month after surgery
The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.
次要结局
- the Blood Loss(one hour after surgery)
- the Operating Time(one hour after surgery)
- The Rate of Conversion to Open Surgery(one hour after surgery)
- First Defecation Time(one week after surgery)
- Postoperative Hospital Stay(one month after surgery)
- the Incidence of Complications(one month after surgery)
- Completeness of Specimens(one hour after surgery)
- Number of Lymph Nodes Dissected(one week after surgery)
- the Incision Length(one hour after surgery)
- Visual Analogue Scale/Score (VAS)(2 days after surgery)
- 3-year DFS (Disease-free Survival)(three years after the operation)
- 5-year OS (Overall Survival)(five years after the operation)
- First Time for Fluid Diet(one week after surgery)
研究者
Dong Yang
Assisted Investigator
Jilin University