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

Colorectal Cancer Clinical Trial

— C-PelvEx-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707598
• Other study ID #: NCC-2023
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: January 11, 2023

Study information

• Verified date: February 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: January 11, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Laparoscopic surgery
The laparoscopic approach was used for the treatment of clinical T4b colorectal cancer

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).	Until the end of the operation, an average of 8 hours.
Primary	Complications	Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.	Until the patient recovered and was discharged from the hospital, an average of 10 days.
Primary	Hospital stay after surgery	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.	Until the patient recovered and was discharged from the hospital, an average of 10 days.
Secondary	Overall survival	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.	The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Secondary	Disease-free survival	Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.	The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.