Laparoscopic vs Open Surgery for Colon Cancer in Patients with Visceral Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this trial, adults with colon cancer and a Body Round Index indicating visceral obesity are randomized to either laparoscopic or open surgical resection. The study focuses on oncologic outcomes and aims to determine if the minimally invasive approach offers similar or superior long-term prognosis in this higher-risk population. Eligible patients have a resectable tumor without distant metastasis and meet specified clinical criteria, with outcomes assessed over time. Prior landmark trials suggested non-inferiority in lean patients, but data in obese populations remain limited, prompting this targeted comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;
2. Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;
3. Tumor lower edge \> 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;
4. Single primary lesion;
5. Aged 18 (inclusive) to 75 (inclusive) years;
6. 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;
7. Treatment-naive, no prior anti-tumor treatment;
8. 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;
9. Patient able to understand the study protocol and willing to participate in the study.

Exclusion Criteria:

1. Height and waist circumference data are unavailable;
2. Hereditary colorectal cancer (Lynch syndrome or Familial Adenomatous Polyposis \[FAP\]);
3. 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;
4. 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);
5. 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;
6. Pregnancy or breastfeeding;
7. Inability to undergo contrast-enhanced CT scan;
8. Additional surgery after EMR or ESD;
9. Patients with unremitted severe mental illness, moderate or above cognitive impairment (MMSE ≤ 23 points), or those who have been hospitalized due to mood disorders in the past year or have unstable antipsychotic medication;
10. Patients with enlarged mesenteric root lymph nodes detected by preoperative CT or intraoperative exploration and suspected metastasis, or suspected metastasis in organs such as peritoneum or liver detected by intraoperative exploration;
11. Patients with a history of major abdominal surgery and severe adhesions precluding laparoscopic surgery upon laparoscopic exploration.

Where it's running

• Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jun Li, M.D.
• Email: 2307016@zju.edu.cn; lj6088@gmail.com
• Phone: +86 13777878061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.