Multivisceral Radical Resection for Surgical T4b Colorectal Cancer(MRRFSTCC)

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05707598
Collaborator
(none)
638
1
10
1941.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic surgery

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.

Study Design

Study Type:
Observational
Actual Enrollment :
638 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Jan 5, 2023
Actual Study Completion Date :
Jan 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Laparoscopic multivisceral resection group

Patients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer

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

Open multivisceral resection group

Patients who underwent open multivisceral resection for clinical T4b colorectal cancer

Outcome Measures

Primary Outcome Measures

  1. Blood loss [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 [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 [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 Outcome Measures

  1. Overall survival [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100021

Sponsors and Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05707598
Other Study ID Numbers:
  • NCC-2023
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jianqiang Tang, Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2023