RecruitingNot ApplicableNCT07314996

Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

A Randomized Controlled Trial of Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

664 participants

Start Date

Jan 18, 2026

Study Type

INTERVENTIONAL

Conditions

Colonic Neoplasms

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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;
Patient able to understand the study protocol and willing to participate in the study.

Exclusion Criteria11

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;
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;
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;
Patients with a history of major abdominal surgery and severe adhesions precluding laparoscopic surgery upon laparoscopic exploration.

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Interventions

PROCEDURELaparoscopic surgery

It refers to the scenario where the necessary anatomy for colon cancer resection is performed using laparoscopic instruments. In laparoscopic surgery, conversion to open surgery is defined as making an abdominal wall incision before completing the predetermined necessary anatomical dissection.This study does not permit the use of hand-assisted laparoscopic surgery, single-port laparoscopic surgery, or robotic surgery. The surgery will be performed according to standards of Complete Mesocolic Excision (CME).

PROCEDUREOpen surgery

It refers to a surgical procedure where the surgeon enters the abdominal cavity through an abdominal wall incision, gains adequate surgical space, and performs anatomical dissection under direct visual guidance, without relying on pneumoperitoneum or laparoscopic camera assistance.