Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

NCT ID: NCT07314996

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 664 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2033-12-31

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.

Detailed Description

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. Further evidence from European waist-to-hip ratio studies and meta-analyses indicates that obese patients-especially those with abdominal obesity-pose greater surgical challenges. For such patients, laparoscopic surgery is associated with fewer harvested lymph nodes, higher conversion rates to open surgery, and potentially compromised surgical quality, which may ultimately lead to inferior long-term prognosis.

The Body Round Index (BRI), calculated using height and waist circumference, serves as a robust predictor of Visceral Fat Area (VFA). It exhibits superior performance to traditional anthropometric indicators such as BMI, waist circumference, and waist-to-hip ratio. Based on BRI and BMI data from Chinese and American populations, as well as clinical observations by the research team, patients with a BRI ≥ 5.0 present with significant visceral fat accumulation, which substantially increases the complexity of surgical procedures.

This study is designed as a prospective, international, multicenter, randomized, open-label, parallel-controlled trial to clarify whether open surgery is superior to laparoscopic surgery in terms of long-term outcomes for colon cancer patients with visceral obesity (defined as BRI ≥ 5.0). Eligible participants meeting all inclusion criteria will be enrolled and randomly assigned in a 1:1 ratio to either the laparoscopic surgery group or the open surgery group. Both groups will undergo surgery adhering to the Complete Mesocolic Excision (CME) standard. Postoperatively, patients will be followed up for 5 years in accordance with the predefined follow-up protocol. The primary outcome measure is the 3-year disease-free survival rate, while secondary outcomes include specimen quality, 30-day postoperative complications and mortality.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic Surgery Group

The abdominal cavity is insufflated to establish a pneumoperitoneum for surgical exposure, and laparoscopic surgery is initiated by inserting the laparoscope through a trocar site into the peritoneal cavity.

Laparoscopic intracorporeal anastomosis is feasible. The specimen must be retrieved through an abdominal wall incision. The dissection sequence is determined by the surgeon's preference.

Group Type: ACTIVE_COMPARATOR

Laparoscopic surgery

Intervention Type: 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 Group

Open surgery involves making an abdominal incision to dissect through the skin, subcutaneous tissue, fascia, and muscle, thereby accessing the peritoneal cavity and enabling direct manual manipulation of intra-abdominal organs for surgical intervention.

Group Type: EXPERIMENTAL

Open surgery

Intervention Type: 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.

Interventions

Laparoscopic 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).

Intervention Type: PROCEDURE

Open 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jun Li

Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Jun Li, M.D.

Role: CONTACT

2307016@zju.edu.cn; lj6088@gmail.com

+86 13777878061

YuRong Jiao

Role: CONTACT

jiaoyurong@zju.edu.cn

+86 13732206364

Facility Contacts

YuRONG Jiao

Role: primary

jiaoyurong@zju.edu.cn

+86 13732206364

Related Links

https://www.who.int/publications/i/item/9789240075634

WHO acceleration plan to stop obesity. Updated July 3, 2023.

https://apps.who.int/gho/data/view.main.CTRY12461?lang=en

Mean body mass index trends among adults, age-standardized (kg/m²) Estimates by country by WHO.

Other Identifiers

SAHZhejiangU Jun Li

Identifier Type: -

Identifier Source: org_study_id