NCT07314996 Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
| NCT ID | NCT07314996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Colonic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 664 participants |
| Start Date | 2026-01-18 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 664 participants in total. It began in 2026-01-18 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07314996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colonic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07314996 currently recruiting?
Yes, NCT07314996 is actively recruiting participants. Contact the research team at 2307016@zju.edu.cn; lj6088@gmail.com for enrollment information.
Where is the NCT07314996 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07314996 clinical trial?
NCT07314996 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 664 participants.