The Role of Mechanical Bowel Preparation in Laparoscopic Right Hemicolectomy With Totally Intracorporeal Anastomosis for Colon Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Surgical Site Infection (SSI)
研究概览
简要总结
This study is a randomized controlled trial conducted at University Medical Center Ho Chi Minh City to evaluate the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer.
Mechanical bowel preparation is commonly used before colorectal surgery to reduce bowel contents and potentially decrease the risk of postoperative infections. However, its benefit remains controversial, particularly in intracorporeal anastomosis, where intra-abdominal contamination may influence surgical outcomes.
In this study, eligible patients will be randomly assigned to one of two groups: with or without mechanical bowel preparation before surgery. The study aims to compare intraoperative events, postoperative complications, and recovery outcomes between the two groups.
The primary outcome is the rate of surgical site infection (SSI) within 30 days after surgery. Secondary outcomes include intraoperative fecal contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters such as time to first bowel movement and length of hospital stay.
The findings of this study are expected to clarify the role of mechanical bowel preparation in reducing postoperative infections and improving surgical outcomes in patients undergoing laparoscopic right hemicolectomy.
详细描述
This randomized controlled trial evaluates the role of mechanical bowel preparation (MBP) in patients undergoing laparoscopic right hemicolectomy with totally intracorporeal anastomosis for colon cancer. Participants are randomly assigned to receive MBP or no MBP prior to surgery using a web-based minimization algorithm. The primary endpoint is surgical site infection within 30 days. Secondary outcomes include intraoperative contamination, anastomotic leakage, postoperative ileus, operative time, and recovery parameters. The study aims to determine whether MBP improves surgical outcomes in this setting.
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 (Investigator)
盲法说明
Participants are aware of their assigned intervention due to the nature of mechanical bowel preparation. The operating surgeons (investigators) are blinded to group allocation. Allocation is concealed using a centralized web-based randomization system, and group assignments are accessible only to designated research staff responsible for preoperative preparation. The allocation is not disclosed to the surgical team prior to surgery. Standardized perioperative protocols are applied to minimize potential bias.
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 colon cancer stage I-III according to the TNM classification
- •Patients undergoing elective right hemicolectomy or extended right hemicolectomy with totally intracorporeal anastomosis at University Medical Center Ho Chi Minh City
- •Postoperative histopathological confirmation of adenocarcinoma
排除标准
- •Patients undergoing emergency surgery
- •Contraindications to mechanical bowel preparation (e.g., bowel obstruction, subobstruction, bowel perforation, or peritumoral abscess)
- •Contraindications to laparoscopic surgery (American Society of Anesthesiologists [ASA] physical status IV or V) or to intracorporeal anastomosis
- •Distant metastasis at the time of surgery (stage IV according to the TNM classification)
- •Recurrent colon cancer after prior surgery
- •Synchronous primary malignancies in other organs
- •Patients undergoing palliative surgery or surgery for tumor-related complications (non-curative intent)
- •Inability to complete follow-up or be contacted
研究组 & 干预措施
Mechanical Bowel Preparation
Participants receive preoperative mechanical bowel preparation according to institutional protocol prior to undergoing laparoscopic right hemicolectomy with intracorporeal anastomosis.
干预措施: Mechanical Bowel Preparation (Other)
No Mechanical Bowel Preparation
Participants undergo laparoscopic right hemicolectomy with intracorporeal anastomosis without preoperative mechanical bowel preparation
干预措施: No mechanical bowel preparation (Other)
结局指标
主要结局
Surgical Site Infection (SSI)
时间窗: Within 30 days after surgery
Surgical site infection (SSI) within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria.
次要结局
- Intraoperative Fecal Contamination(During surgery)
- Anastomotic Leakage(Within 30 days after surgery)
- Postoperative Ileus(Within 30 days after surgery)
- Operative Time(During surgery)
研究者
Trần Đức Huy
Consultant Colorectal surgeon
University Medical Center Ho Chi Minh City (UMC)