Clinical trial

Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07314996

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionColonic Neoplasms

Full registry 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.

Treatments and study arms

Laparoscopic surgery

Procedure

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).

Open surgery

Procedure

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.

Primary outcomes

Three-year disease-free survival (DFS)36 months post-randomization

Disease free survival(DFS)was defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, any new primary cancer, or death from any cause

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Second Affiliated Hospital of Zhejiang University School of Medicine🇨🇳 Hangzhou, Zhejiang, China
YuRONG JiaoContact