Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers think visceral obesity—the buildup of fat inside the abdomen—can make keyhole (laparoscopic) colon surgery more difficult and may reduce the quality of the operation. This randomised trial is testing whether open surgery or laparoscopic surgery gives better outcomes in people with visceral obesity.
Earlier comparisons found similar outcomes with laparoscopic and open surgery, but included relatively few people with substantial abdominal obesity. The trial is measuring three-year disease-free survival—how long people remain alive without detectable cancer after treatment—to see whether either approach provides better cancer control in this group.
Worth knowing: The comparison concerns surgical approach, and the main outcome is disease-free survival rather than overall survival or short-term effects such as complications and recovery time.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07314996 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 664 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Laparoscopic surgery
- Procedure Open surgery
What it is measuring
Three-year disease-free survival (DFS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
Study on Surgical Approaches for Colon Cancer Patients with Visceral Obesity
Colorectal cancer stands as a major malignant tumor threatening human health. Laparoscopic surgery has been widely adopted in colon cancer treatment, as it yields comparable survival outcomes to open surgery while offering the advantage of minimal invasiveness. However, with the global escalation of obesity, laparoscopic intervention becomes increasingly challenging in colon cancer patients with visceral obesity, potentially compromising surgical quality.
Notably, earlier landmark studies including COST, COLOR, and CLASICC have confirmed that laparoscopic surgery is non-inferior to open surgery in colon cancer patients. Nevertheless, these studies enrolled relatively lean patients with a Body Mass Index (BMI) below the average level of their respective regions; the COLOR study even excluded patients with a BMI exceeding 30 kg/m². Additionally, transverse colon cancer and splenic flexure colon cancer were excluded from these trials, rendering their data insufficiently representative of the growing population of obese colon cancer patients.
In contrast, the JCOG0404 study specifically demonstrated that colon cancer patients with a BMI ≥ 25 kg/m² had significantly poorer prognostic outcomes after laparoscopic surgery compared to open surgery.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Colon
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07314996, registered by Second Affiliated Hospital, Zhejiang University, School of Medicine on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.