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Enrolling by invitation Not applicable

Outcome of Resection for Colorectal Cancer

NCT03837782 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2019-02-15
Last updated
2019-02-12

Condition(s) studied

Laparoscopy

Investigational drug(s) / intervention(s)

minimally invasive surgery

minimally invasive surgery: Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.

Study summary

There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal cancer.

This trial is a multicenter,prospective, randomized trial evaluating short-term and survival outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: (i) tumor without distant metastasis; (ii) classified as stage I, II or III by TNM staging system; (iii) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; (iv) a minimum of 12 lymph nodes resected to accurately identify stage; (v) solitary malignant lesion after thorough colonoscopy; (vi) complete resection (R0) with no positive nodes left behind; (vii) histological diagnosis of adenocarcinoma. Exclusion Criteria: (i) \<18 years or \>90 years; (ii) serious concurrent illness; (iii) clinically suspicious distant metastasis detected by positron emission tomography-computed tomography (PET-CT); (iv) familial adenomatous polyposis syndrome (FAP), hereditary non-polyposis colorectal cancer (HNPCC) and other hereditary CRC; (v) postoperative pathological close, indeterminate, or positive margins; (vi) circumferential resection margin \< 1mm in rectal cancer; (vii) short anticipated life expectancy due to postoperative comorbidities on account of cardiopulmonary insufficiency.

Primary outcome measure(s)

  • complications — through hospital stay, an average of two weeks
    complications includes intraoperative and postoperative complications, such as huge blood loss, anastomotic fistula, abdominal infection and septic shock.
  • disease free survival — From date of randomization until the date of first documented progression, assessed up to 70 months
    Disease-free survival (DFS) was defined as the interval between the date of surgical resection and diagnosis of recurrence or the most recent follow-up date.
  • overall survival — From date of randomization until the date of death from any cause, assessed up to 70 months.
    Overall survival (OS) was measured from the date of hepatectomy to death with or without HCC recurrence or the end of this study period.

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03837782 on ClinicalTrials.gov ↗ ← All trials in China