Colonic NeoplasmsLOVONCT07314996
Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
A study testing Laparoscopic surgery and Open surgery in people with Colonic Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Laparoscopic surgery and Open surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2026to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;
- Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;
- Tumor lower edge > 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;
- Single primary lesion;
- Aged 18 (inclusive) to 75 (inclusive) years;
- 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;
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- Treatment-naive, no prior anti-tumor treatment;
- 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;
- Patient able to understand the study protocol and willing to participate in the study.
Who cannot join
- Height and waist circumference data are unavailable;
- Hereditary colorectal cancer (Lynch syndrome or Familial Adenomatous Polyposis [FAP]);
- 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;
- 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);
- 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;
- Pregnancy or breastfeeding;
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- Inability to undergo contrast-enhanced CT scan;
- Additional surgery after EMR or ESD;
- 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;
- 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;
- Patients with a history of major abdominal surgery and severe adhesions precluding laparoscopic surgery upon laparoscopic exploration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
YuRONG Jiao, +86 13732206364, jiaoyurong@zju.edu.cn
About this study
Official title: A Randomized Controlled Trial of Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
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.
Read the 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
- Being tested
- Laparoscopic surgery, Open surgery
- Keywords
- laparoscopic surgery, open surgery, Body Round Index (BRI), complete mesocolic excision, oncologic outcome, specimen quality
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or 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).
Open surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery Group | Active comparator | 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. Receives: Procedure: Laparoscopic surgery |
| Open Surgery Group | Experimental | 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. Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-year disease-free survival (DFS)
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
Measured: 36 months post-randomization
Secondary outcomes (9)
Length of colon resected
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Length of small bowel resected
Limited to right hemicolectomy. Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Distance between tumor and closest arterial vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Distance between nearest bowel wall and the same vascular division
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Area of mesentery resected
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Mesocolic grading
Follow the criteria described by Professor West's criteria (Lancet Oncol 2008，PMID: 18667357). This classification system includes three grades: Mesocolic plane, Intramesocolic plane, Muscularis propria plane.
Measured: 2 weeks post operation.
Number of lymph nodes harvested
Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)
Measured: 2 weeks post operation.
Incidence of intraoperative complications
Intraoperative complications refer to accidents that occur during surgery. Complications may cause harm to the patient or threaten their life safety (such as iatrogenic intestinal injury, vascular injury or other organ injuries, severe bleeding, cardiovascular and cerebrovascular events or respiratory dysfunction that lead to the interruption of surgery, etc.). These events may result in the prolongation of the surgery, changes in the surgical method, unplanned medical interventions, or even endanger the patient's life.
The study provides classifications and definitions of common complications. For complications not included in the classification table, refer to the Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
Measured: From the start of surgical skin incision to the completion of skin suturing.
Incidence 30-day postoperative complications
Postoperative complications refer to symptoms and signs diagnosed through imaging or clinical evaluation after surgery .
The study provides classifications and definitions of common complications. For complications not included in the classification table, refer to the Common Terminology Criteria for Adverse Events (CTCAE) V6.0.
Measured: From the completion of skin suturing to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start18 Jan 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly assigned in a 1:1 ratio to undergo laparoscopic surgery or open surgery. Both groups adhered to the principles of Complete Mesocolic Excision (CME), with at least D2 lymph node dissection performed. For patients with suspected mesenteric lymph node metastasis detected by preoperative CT, D3 lymph node dissection was feasible. The intestinal segments 10 cm or more proximal and distal to the tumor were resected.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 664 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Li, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314996
- Sponsor's protocol ID
- SAHZhejiangU Jun Li
- Acronym
- LOVO
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the requirements of the International Committee of Medical Journal Editors, the de-identified raw data of this study will be made public after the results are published. The access method will be stated when the research results are published.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity
- ClinicalTrials.gov ID
- NCT07314996
- Acronym / sponsor ID
- LOVO / SAHZhejiangU Jun Li
- Conditions
- Colonic Neoplasms
- Keywords
- laparoscopic surgery, open surgery, Body Round Index (BRI), complete mesocolic excision, oncologic outcome, specimen quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 664 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Jan 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned in a 1:1 ratio to undergo laparoscopic surgery or open surgery. Both groups adhered to the principles of Complete Mesocolic Excision (CME), with at least D2 lymph node dissection performed. For patients with suspected mesenteric lymph node metastasis detected by preoperative CT, D3 lymph node dissection was feasible. The intestinal segments 10 cm or more proximal and distal to the tumor were resected.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery Group | Active comparator | Procedure: Laparoscopic surgeryThe 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. |
| Open Surgery Group | Experimental | Procedure: Open surgeryOpen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body Roundness Index (BRI) ≥ 5.0, with no laparoscopic surgery contraindications as assessed by the surgeon;
- Pathologically confirmed colon adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma;
- Tumor lower edge > 12 cm from the anus as measured by colonoscopy, and the tumor lower edge not directly palpable by digital rectal examination;
- Single primary lesion;
- Aged 18 (inclusive) to 75 (inclusive) years;
Key exclusion criteria (11 listed)
- Height and waist circumference data are unavailable;
- Hereditary colorectal cancer (Lynch syndrome or Familial Adenomatous Polyposis [FAP]);
- 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;
- 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);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic surgeryIt 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). | Procedure or surgery | Laparoscopic Surgery Group |
| Open surgeryIt 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. | Procedure or surgery | Open Surgery Group |
Primary outcome
Three-year disease-free survival (DFS)
Time frame: 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
9 secondary outcomes
Length of colon resected
Time frame: 2 weeks post operation.
Length of small bowel resected
Time frame: 2 weeks post operation.
Distance between tumor and closest arterial vascular division
Time frame: 2 weeks post operation.
Distance between nearest bowel wall and the same vascular division
Time frame: 2 weeks post operation.
Area of mesentery resected
Time frame: 2 weeks post operation.
Mesocolic grading
Time frame: 2 weeks post operation.
Number of lymph nodes harvested
Time frame: 2 weeks post operation.
Incidence of intraoperative complications
Time frame: From the start of surgical skin incision to the completion of skin suturing.
Incidence 30-day postoperative complications
Time frame: From the completion of skin suturing to 30 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- WHO acceleration plan to stop obesity. Updated July 3, 2023.Link provided by the sponsor.
- Mean body mass index trends among adults, age-standardized (kg/m²) Estimates by country by WHO.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with the requirements of the International Committee of Medical Journal Editors, the de-identified raw data of this study will be made public after the results are published. The access method will be stated when the research results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgery and Open surgery in people with Colonic Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, M.D. (+86 13777878061, 2307016@zju.edu.cn; lj6088@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-year disease-free survival (DFS) (time frame: 36 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.