Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic surgery

    Procedure/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 surgery

    Procedure/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.

Treatment groups

664 Participants
are divided into 2 treatment groups
Group A: Laparoscopic Surgery GroupActive comparator 1 intervention
Group B: Open Surgery GroupExperimental treatment 1 intervention

Trial outcomes

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

Time frame
36 months post-randomization

Secondary outcomes

1

Length of colon resected

Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)

Time frame
2 weeks post operation.
2

Length of small bowel resected

Limited to right hemicolectomy. Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)

Time frame
2 weeks post operation.
3

Distance between tumor and closest arterial vascular division

Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)

Time frame
2 weeks post operation.
4

Distance between nearest bowel wall and the same vascular division

Follow the criteria described by Professor Quirke's criteria (BJS 2014, PMID: 25139143)

Time frame
2 weeks post operation.

Other outcomes

1

Quality of life of patients

The EORTC QLQ-C30 scale was adopted. The corresponding language version was selected according to the patient's place of origin.

Time frame
The survey time points included: preoperatively, 5 days postoperatively, 1 month postoperatively, and 12 months postoperatively.
2

Incidence of postoperative abdominal wall incisional hernia

Diagnostic criteria: The surgical incision area in this study is characterized by an abdominal wall defect with abdominal contents protruding outward through the defect; physical examination shows a significant bulging of the hernia mass when standing or when abdominal pressure increases (e.g., coughing, breath-holding), and the hernia mass can spontaneously reduce when lying down (excluding incarcerated/strangulated incisional hernias). The above lesions must be clearly confirmed by abdominal computed tomography (CT) examination (including three-dimensional reconstruction). (Guidelines for diagnosis and treatment of abdominal wall incision hernia (2024 edition), PMID: 39794142)

Time frame
24-36 months postoperatively
3

5-year overall survival rate

The proportion of patients who survived 5 years from randomization.

Time frame
5 years from randomization.

Sponsors and contacts

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