Effect of Preserving the Left Colic Artery on Proximal Bowel and Anastomotic Blood Perfusion During Radical Resection for Rectal Cancer: A Randomized Controlled Trial Based on Laser Speckle Contrast Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 143
- 主要终点
- Maximum Perfusion Distance (MPD)
研究概览
简要总结
Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Proximal bowel blood perfusion will be measured using Laser Speckle Contrast Imaging, and the perfusion characteristics will be compared between the two ligation groups.
Additionally, for participants randomized to the LT group, an embedded prospective cohort sub-study will be performed. This sub-study involves controlled, temporary intraoperative occlusion of the preserved Left Colic Artery (LCA). During this temporary occlusion, LSCI will be used to assess the resulting changes in colonic perfusion, specifically measuring outcomes like the ischemic demarcation line (LOD) retraction distance, to further investigate the functional contribution of the preserved LCA. The overall trial aims to determine the optimal IMA ligation strategy based on objective perfusion data and a deeper understanding of LCA's role.
详细描述
The primary goal of this clinical trial is to compare proximal bowel blood perfusion following HT versus LT of the IMA during anterior resection for rectal cancer. LSCI will be used to assess perfusion in both groups.Additionally, this trial incorporates an embedded prospective cohort sub-study, which will be conducted specifically within the LT group, where the Left Colic Artery (LCA) is preserved. The purpose of this sub-study is to further elucidate the impact of this LCA preservation on left colonic perfusion in these patients. This will be achieved by investigating the retraction distance of the ischemic demarcation line following temporary occlusion of the preserved LCA under LSCI guidance, and by exploring potential anatomical and pathophysiological factors that may contribute to variations in this retraction distance.
The main questions the study seeks to answer are:
Does HT ligation result in significantly different proximal bowel blood perfusion, as measured by LSCI, compared to LT ligation? Does knowledge of intraoperative bowel perfusion, as assessed by LSCI, influence surgical decision-making, specifically regarding changes to the planned transection line? Are there significant differences in quantified perfusion intensity at the transection line between HT and LT ligation techniques? What is the retraction distance of the ischemic demarcation line, observed via LSCI, following temporary occlusion of the LCA, and what are the potential anatomical or pathophysiological factors associated with variations in this distance? Patients undergoing anterior resection for rectal cancer will be randomized to receive either HT or LT ligation of the IMA. LSCI will be used intraoperatively to assess bowel perfusion.
Participants will:
Undergo anterior resection for either rectal or rectosigmoid cancer, with HT or LT ligation of the IMA determined by the randomization process.
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 study employs single-blinding where patients are unaware of their treatment allocation (High Tie [HT] or Low Tie [LT]). The operating surgeon is necessarily unblinded intraoperatively to perform the assigned surgical technique. The statistician(s) performing the data analysis will be masked to treatment group assignments until the analysis is complete. Randomization is managed by a designated investigator using pre-generated random numbers after eligibility confirmation (1:1 ratio to HT or LT group).
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
- •a confirmed diagnosis based on pathological reports;
- •patients who had not received any prior treatment;
排除标准
- •a history of previous abdominal surgery or neoadjuvant chemotherapy/radiation affecting bowel perfusion or anastomosis;
- •patients requiring emergency surgery due to acute complications;
- •intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.
研究组 & 干预措施
HT Group
In this group, the IMA was ligated approximately 1 cm from its origin. With this approach, both the LCA and the inferior mesenteric vein were ligated near the lower border of the pancreas.
干预措施: High Tie of Inferior Mesenteric Artery (Procedure)
LT Group
In the LT group, apical lymph node dissection was performed around the origin of the IMA. During this procedure, the LCA was identified and preserved and the superior rectal artery was ligated.
干预措施: Low Tie of Inferior Mesenteric Artery (Procedure)
结局指标
主要结局
Maximum Perfusion Distance (MPD)
时间窗: Perioperative
Determined by measuring the distance from the ischemic line of demarcation to the starting point of the sigmoid colon.
次要结局
- Number of participants requiring revision of the planned bowel transection line following intraoperative Laser Speckle Contrast Imaging (LSCI)-based bowel perfusion assessment(Perioperative)
- Speckle Flow Index (SFI) at the Proximal Anastomosis Site Measured by Laser Speckle Contrast Imaging (LSCI)(Perioperative)
- Ischemic Demarcation Line (LOD) Retraction Distance(Perioperative)