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Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05707598
Acronym
C-PelvEx-01
Enrollment
638
Registered
2023-02-01
Start date
2023-01-01
Completion date
2023-01-11
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Multivisceral resection, Laparoscope

Brief summary

This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.

Detailed description

Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer. This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.

Interventions

PROCEDURELaparoscopic surgery

The laparoscopic approach was used for the treatment of clinical T4b colorectal cancer

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation. 2. All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation. 3. All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation.

Exclusion criteria

Patients with distant metastasis or recurrent colorectal cancer were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Blood lossUntil the end of the operation, an average of 8 hours.Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
ComplicationsUntil the patient recovered and was discharged from the hospital, an average of 10 days.Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Hospital stay after surgeryUntil the patient recovered and was discharged from the hospital, an average of 10 days.Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days.

Secondary

MeasureTime frameDescription
Overall survivalThe endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Disease-free survivalThe endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026