Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of Anastomotic Leakage
研究概览
简要总结
Study Description This prospective, controlled clinical study aims to compare the clinical outcomes of reinforced anastomosis using 8-10 interrupted sutures versus the conventional Dixon procedure in patients undergoing laparoscopic low anterior resection for low rectal cancer. Anastomotic leakage remains one of the most significant postoperative complications following low rectal cancer surgery, particularly in laparoscopic procedures due to limited tactile feedback and maneuverability in the pelvic cavity.
Reinforcement of the anastomotic site through additional interrupted suturing may provide better mechanical strength and improved healing, potentially reducing the incidence of anastomotic leakage and related morbidities. In this study, eligible patients will be assigned to receive either a conventional laparoscopic Dixon procedure or the same procedure with added reinforcement of the anastomosis using 8-10 interrupted sutures circumferentially.
Perioperative outcomes including the rate of anastomotic leakage, postoperative complications, operation time, length of hospital stay, return of bowel function, and quality of life will be assessed and compared between the two groups. The study seeks to provide evidence for optimizing surgical techniques in low rectal cancer treatment and improving patient prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years.
- •Diagnosed with low rectal adenocarcinoma located within 7 cm from the anal verge by colonoscopy and biopsy.
- •Scheduled for elective laparoscopic low anterior resection (Dixon procedure).
- •Clinical stage I-III (based on preoperative imaging, e.g., MRI/CT) without distant metastasis.
- •Adequate organ function (hematologic, hepatic, renal) to tolerate surgery.
- •Provided written informed consent and willing to comply with study procedures and follow-up.
排除标准
- •Presence of synchronous distant metastases or other malignancies.
- •History of prior pelvic radiotherapy or major pelvic surgery.
- •Severe uncontrolled comorbidities (e.g., severe cardiovascular, respiratory, hepatic or renal insufficiency).
- •Emergency surgery indication (e.g., bowel obstruction, perforation).
- •Pregnancy or breastfeeding.
- •Known allergy or contraindication to anesthesia or surgical materials used.
- •Participation in another interventional clinical trial within the last 3 months.
研究组 & 干预措施
Reinforced Anastomosis with 8-10 Interrupted Sutures
Patients in this group will undergo laparoscopic low anterior resection (Dixon procedure) for low rectal cancer, followed by reinforcement of the anastomosis using 8-10 interrupted seromuscular sutures circumferentially around the stapled anastomotic site. The reinforcement is intended to enhance anastomotic integrity and reduce the risk of leakage.
干预措施: Reinforced Anastomotic Suturing (8-10 Interrupted Sutures) (Procedure)
Conventional Dixon Procedure
Patients in this group will undergo standard laparoscopic low anterior resection (Dixon procedure) for low rectal cancer without additional reinforcement of the anastomosis. The anastomosis will be performed using a circular stapler alone, as per conventional practice.
干预措施: Conventional Laparoscopic Dixon Procedure (Procedure)
结局指标
主要结局
Incidence of Anastomotic Leakage
时间窗: Within 30 days postoperatively
Defined as clinically significant leakage confirmed by radiological or surgical evidence, classified according to International Study Group of Rectal Cancer (ISREC) criteria.
次要结局
- Postoperative Complication Rate(Up to 30 days after surgery)
- Operation Time(During the surgical procedure)
- Length of Postoperative Hospital Stay(From date of surgery through date of discharge, up to 30 days)
研究者
Zhang Feng-Min
Investigator assistant
Shanghai 10th People's Hospital