NCT05707598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Last Updated

December 27, 2024

Status Verified

February 1, 2023

Enrollment Period

4 days

First QC Date

January 12, 2023

Last Update Submit

December 21, 2024

Conditions

Colorectal Cancer

Keywords

Colorectal cancerMultivisceral resectionLaparoscope

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Laparoscopic multivisceral resection group

Patients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer

Procedure: Laparoscopic surgery

Open multivisceral resection group

Patients who underwent open multivisceral resection for clinical T4b colorectal cancer

Interventions

Laparoscopic surgeryPROCEDURE

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

Laparoscopic multivisceral resection group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with distant metastasis or recurrent colorectal cancer were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 1, 2023

Study Start

January 1, 2023

Primary Completion

January 5, 2023

Study Completion

January 11, 2023

Last Updated

December 27, 2024

Record last verified: 2023-02

Locations

CN(1)