跳至主要内容
临床试验/NCT07189780
NCT07189780尚未招募不适用

Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.

First Affiliated Hospital of Wenzhou Medical University0 个研究点目标入组 200 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Estimated Blood Loss

研究概览

简要总结

Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.

In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.

Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.

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
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Pathologically confirmed rectal adenocarcinoma.
  • •Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).
  • •Body mass index (BMI) ≤ 30 kg/m².
  • •Tumors with the distal margin located ≤ 10 cm from the anal verge.
  • •Absence of distant metastases (e.g., to the liver, lungs, or other organs).

排除标准

  • •Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).
  • •History of malignancy in other organs.
  • •Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.
  • •Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.
  • •Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.

研究组 & 干预措施

Experimental Group

Experimental

Experimental Group:Entering the dissection plane by incising the peritoneum precisely at the lowest point of the peritoneal reflection.

干预措施: Surgical approach (Procedure)

Control Group

Active Comparator

Control Group:Entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection.

干预措施: Surgical approach (Procedure)

结局指标

主要结局

Estimated Blood Loss

时间窗: 2-6hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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