Clinical trial NCT05707598: Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches
Official title: Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Multivisceral resection
Laparoscope
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. The patients were diagnosed with colorectal cancer and the tumor was considered to have invaded the adjacent organs before surgery.
2. The patient experienced multivisceral resection for surgical T4b colorectal cancer from January 2010 to December 2021.
3. All of the operations were performed with either open or laparoscopic surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss
timeFrame: Until the end of the operation, an average of 8 hours.
measure: Complications
timeFrame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
measure: Hospital stay after surgery
timeFrame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Secondary outcomes:
measure: Overall survival
timeFrame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
measure: Disease-free survival
timeFrame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: