Not Yet RecruitingNot Applicable

Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

China664 participantsStarted 2026-01-01

Plain-language summary

This study aims to elucidate whether there is a difference in long-term prognosis between laparoscopic surgery and open surgery in colon cancer patients with visceral obesity.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;
✓. Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;
✓. Tumor lower edge \> 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;
✓. Single primary lesion;
✓. Aged 18 (inclusive) to 75 (inclusive) years;
✓. Clinical stage T3/4Nany or T1-4N+ on chest non-contrast CT and abdominal enhanced CT, no distant metastasis, and resectable as judged by the surgeon;
✓. Treatment-naive, no prior anti-tumor treatment;
✓. Completed blood routine, liver and kidney function tests, carcinoembryonic antigen (CEA), and carbohydrate antigen 199 (CA199) before randomization, with American Society of Anesthesiologists (ASA) score ≤ III;

Exclusion criteria

✕. Height and waist circumference data are unavailable;
✕. Hereditary colorectal cancer (Lynch syndrome or Familial Adenomatous Polyposis \[FAP\]);
✕. History of previous malignant neoplasm, with the exception of basal cell carcinoma/papillary thyroid carcinoma/various types of in situ cancers/micro-invasive early-stage lung cancer;
✕. Acute exacerbation of major organ diseases (such as, but not limited to, COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as, but not limited to, hepatitis, pneumonia, and myocarditis);
✕. The tumor presents with obstruction or is at high risk of obstruction, and/or there is bleeding and/or perforation, which may necessitate emergency surgery;
✕. Pregnancy or breastfeeding;
✕. Inability to undergo contrast-enhanced CT scan;
✕. Additional surgery after EMR or ESD;

What they're measuring

Three-year disease-free survival (DFS)

Timeframe: 36 months post-randomization

Trial details

NCT IDNCT07314996

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-12-31

Contact for this trial

Jun Li, M.D.

+86 13777878061 2307016@zju.edu.cn; lj6088@gmail.com

View on ClinicalTrials.gov More Colonic Neoplasms trials