NCT07314996

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for not_applicable

Timeline
92mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Dec 2033

First Submitted

Initial submission to the registry

December 4, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

January 18, 2026

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

June 3, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

December 4, 2025

Last Update Submit

June 1, 2026

Conditions

Colonic Neoplasms

Keywords

laparoscopic surgeryopen surgeryBody Round Index (BRI)complete mesocolic excisiononcologic outcomespecimen quality

Outcome Measures

Primary Outcomes (1)

  • 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

    36 months post-randomization

Secondary Outcomes (9)

  • Length of colon resected

    2 weeks post operation.

  • Length of small bowel resected

    2 weeks post operation.

  • Distance between tumor and closest arterial vascular division

    2 weeks post operation.

  • Distance between nearest bowel wall and the same vascular division

    2 weeks post operation.

  • Area of mesentery resected

    2 weeks post operation.

  • +4 more secondary outcomes

Other Outcomes (3)

  • Quality of life of patients

    The survey time points included: preoperatively, 5 days postoperatively, 1 month postoperatively, and 12 months postoperatively.

  • Incidence of postoperative abdominal wall incisional hernia

    24-36 months postoperatively

  • 5-year overall survival rate

    5 years from randomization.

Study Arms (2)

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.

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.

Procedure: Open surgery

Interventions

Laparoscopic surgeryPROCEDURE

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).

Laparoscopic Surgery Group
Open surgeryPROCEDURE

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.

Open Surgery Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

LaparoscopyConversion to Open Surgery

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Jun Li, M.D.

CONTACT

+86 137778780612307016@zju.edu.cn; lj6088@gmail.com

YuRong Jiao

CONTACT

+86 13732206364jiaoyurong@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 2, 2026

Study Start

January 18, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2033

Last Updated

June 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The access method will be stated when the research results are published.
Access Criteria
To access the Individual Participant Data (IPD), a detailed data usage plan must be submitted, specifying the research objectives and study content, which will be approved following review by the Principal Investigator (PI) of this study.
More information

Locations

CN(1)