Actively Recruiting
A Randomized Controlled Trial of Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-06-03
664
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether there is a difference in long-term outcomes between laparoscopic surgery and open surgery for colon cancer patients who have visceral obesity. This condition presents challenges for laparoscopic surgery, which is generally less invasive and has similar survival rates to open surgery. Previous studies mainly involved lean patients and excluded those with higher body mass indexes, while this trial focuses on patients with a higher Body Roundness Index (BRI 6 5.0) to better represent those with significant visceral fat. The study is a prospective, international, multicenter, randomized clinical trial. Participants will be randomly assigned to one of two surgical groups: laparoscopic surgery or open surgery. Both groups will undergo surgery following the Complete Mesocolic Excision (CME) standard. Laparoscopic surgery involves inflating the abdomen and using small incisions with a camera and instruments, while open surgery involves a larger abdominal incision allowing direct manual access. After surgery, patients will be followed for five years to monitor outcomes. Participants will undergo several assessments, including blood tests, imaging scans, and pathological evaluations. Researchers will measure the primary outcome of three-year disease-free survival, along with secondary outcomes such as specimen quality, postoperative complications within 30 days, and mortality. Follow-up visits will monitor health status over five years to evaluate surgical effectiveness and safety in this specific patient population.
CONDITIONS
Brief Title
Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Roundness Index (BRI) 6 5.0, with no contraindications for laparoscopic surgery as judged by the surgeon
- Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma
- Tumor lower edge more than 12 cm from the anus measured by colonoscopy and not palpable by digital rectal exam
- Single primary lesion only
- Age between 18 and 75 years inclusive
- Clinical stage T3/4Nany or T1-4N+ with no distant metastasis and judged resectable by the surgeon
- No prior anti-tumor treatment
- Completed routine blood tests, liver and kidney function, CEA and CA199 tests; ASA score of III or less
- Able to understand study protocol and willing to participate
You will not qualify if you...
- Missing height or waist circumference data
- Hereditary colorectal cancer such as Lynch syndrome or Familial Adenomatous Polyposis (FAP)
- History of previous malignant tumors except certain early-stage or in situ cancers
- Acute exacerbation of major organ diseases or severe acute infections
- Tumor causing or at high risk of obstruction, bleeding, or perforation requiring emergency surgery
- Pregnancy or breastfeeding
- Unable to undergo contrast-enhanced CT scan
- Additional surgery needed after EMR or ESD
- Severe mental illness, moderate or worse cognitive impairment, or recent unstable psychiatric conditions
- Enlarged lymph nodes or suspected metastasis detected by imaging or surgery
- History of major abdominal surgery with severe adhesions preventing laparoscopic surgery during exploration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo either laparoscopic or open surgery for colon cancer following the Complete Mesocolic Excision (CME) standard. This stage includes the surgery procedure and immediate post-operative care until hospital discharge.
1 surgical visit and daily post-operative assessments during hospital stay
Duration - 5 years
Participants are followed up for assessment of recovery, complications, and oncological outcomes after surgery, including monitoring for 30-day postoperative complications and long-term disease-free survival.
Regular follow-up visits according to protocol, including assessments at 2 weeks post-operation and periodic visits up to 5 years
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jun Li, M.D.
Y
YuRong Jiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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