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โ† Trials
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Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

RecruitingNAAges 18 Years - 75 YearsAllCancer Institute and Hospital, Chinese Academy ofโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patient age between 18-75 years. 2. Colonic biopsy pathology confirms adenocarcinoma. 3. The inferior margin of the primary tumor is โ‰ค 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis. 4. At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3. 5. At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery. 6. At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three. 7. Strong willingness for surgery and signed informed consent. Exclusion Criteria: 1. Previous history of malignant colorectal tumors. 2. Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma. 3. Imaging diagnosis of distant metastasis. 4. Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions. 5. Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery. 6. Extensive lesions not amenable to R0 resection. 7. Diagnosed with other malignancies within the past five years. 8. ASA (American Society of Anesthesiologists) classification โ‰ฅ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score โ‰ฅ 2. 9. Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery. 10. History of severe mental illness. 11. Pregnant or breastfeeding women.
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What it tests

  • Dissection of the No.253 lymph node
  • Omitting the dissection of the No.253 lymph node
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Where

8 sites
Peking Union Medical College Hospital
Beijing, China
China-Japan Friendship Hospital
Beijing, China
Beijing Cancer Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
West China Hospital Sichuan University
Chengdu, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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