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CompletedNCT05707598C-PelvEx-01Updated Dec 27, 2024

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

An observational study in Colorectal Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
638
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • Multivisceral resection
  • Laparoscope
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In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 638 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with distant metastasis or recurrent colorectal cancer were excluded.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
638 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureLaparoscopic surgery

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

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What researchers measure

Primary outcomes

  1. Blood loss

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

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

  2. Complications

    Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.

    Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.

  3. 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.

    Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

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Study locations

1 site
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
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References and documents

Publications

  • Zhang J, Sun J, Liu J, Mei S, Quan J, Hu G, Li B, Zhuang M, Wang X, Tang J. Comparison of short- and long-term outcomes between laparoscopic and open multivisceral resection for clinical T4b colorectal cancer: A multicentre retrospective cohort study in China. Eur J Surg Oncol. 2024 Jan;50(1):107316. doi: 10.1016/j.ejso.2023.107316. Epub 2023 Dec 7. PubMed 38086316 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05707598
Responsible party
Jianqiang Tang (Associate professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Feb 1, 2023
Start date
Jan 1, 2023
Primary completion
Jan 5, 2023
Completion
Jan 11, 2023
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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