跳至主要内容
临床试验/NCT05685680
NCT05685680招募中不适用

Outcome of Laparoscopic Total Mesorectal Excision Versus Open Technique in Management of Rectal Carcinoma

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.

研究概览

简要总结

Colorectal cancer is the second leading cause of death in the West, and rectal cancer accounts for about 25% of colon cancers

Low anterior resection has been the mainstay of rectal cancer surgery in low rectal cancer since the 1970s. Although the best efforts of experienced surgeons, The local recurrence rate is 3 to 33% in conventional surgery, while total mesorectal excision (TME) results indicate a recurrence rate of less than 10%

The evolution of the concept of TME which was first revealed by Heald.in 1982 made a major shift in the treatment strategies (Rodriguez-Luna et al,2015). The concept of TME was the most important event in surgery for rectal cancer in the last two decades, because even without a curative approach, the local recurrence decreased to 6 to 12%, and 5-year survival improved by 53-87% TME described clear definitions of distal resection margin (DRM), circumferential resection margin (CRM), and least number of harvested lymph nodes, so oncological outcomes improved, locoregional recurrence and survival rates also influenced .

Laparoscopic total mesorectal excision (LTME) may be associated with less blood loss, earlier recovery, and lower morbidity. Identification of the small nerves and vessels became easiear because of laparoscopic magnified view of pelvis and thus prevents these injuries (Sajid et al, 2019). Also, minimal surgical trauma will reduce the immunologic response and preserves postoperative immunologic defenses. This may lead to low rate of infections as well as low local recurrences and distant metastases in addition to, tissue handling with less manipulation, 'may reduces the spread of cancer cells

TME in obese males with low and anterior rectal tumors is technically challenging especially post neoadjuvant chemoradiotherapy due to distortion of the anatomical planes (Ng et al, 2014). In these patients, it is difficult to obtain a proper view of the dissection plane, in open technique which threatens the integrity of TME and carries the risk of positive margins, which is related to higher rates of local recurrence

LTME is a widely used approach for rectal cancers; although conversion rate varies from 1.2 to 17%, and it is higher if BMI is equal to or more than 30

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

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with pathologically confirmed rectal carcinoma involving middle or lower third rectum and operable by MRI and CT scan criteria.
  • Both sexes will be included.
  • Age: ranging from 20 to 70 years.

排除标准

  • Patients with stage IV.
  • Recurrent rectal cancers.
  • Combined malignancy.
  • Patients admitted due to emergency situations (acute large bowel obstruction, abdominal abscess, or rectal perforation and hemorrhage).
  • Patients with contraindication for laparoscopic surgery.
  • Unfit patients (ASA score > II).

结局指标

主要结局

Comparison betewen laparoscopic and open teqnique in resection of rectal carcinoma and the involvement of the resection margin (R1), which is CRM involvement or DRM involvement.after resection.

时间窗: 1year

R(resection margin of cancer of rectum) CRM circumferencial margin Or. DRM distal resection margin of cancer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Saleh Ahmed

Assistant lecture ofgeneral surgery

Sohag University

研究点 (1)

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