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NCT Number: NCT05707598

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients with distant metastasis or recurrent colorectal cancer were excluded.

Treatment and study plan

Laparoscopic surgery

Procedure

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

Primary outcomes

  1. Blood loss

    Time frame: Until the end of the operation, an average of 8 hours.

    Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).

  2. Complications

    Time frame: Until 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.

  3. Hospital stay after surgery

    Time frame: Until 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 outcomes

  1. Overall survival

    Time frame: The 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.

  2. Disease-free survival

    Time frame: The 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.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Acronym: C-PelvEx-01

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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