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The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy
NCT07138859 · The Affiliated Hospital of Qingdao University · Updated 24 Aug 2025
- What is being tested
- Robot assisted radical right hemicolectomy (D3 lymph node dissection); Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)
- For
- Colorectal Carcinoma (CRC); Right Hemicolectomy
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 80 years. About 368 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started Aug 2025, ends Dec 2030. Registered 24 Aug 2025.
- Results
- None posted yet.
In the researchers' words
Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes. This experimental design was based on a 1:1 effective target case ratio between the experimental group and the control group for enrollment. The experimental group underwent robotic radical right hemicolectomy (D3 lymph node dissection), while the control group underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection). The unedited surgical videos of patients were analyzed, and relevant indicators and adverse events were recorded. Patients were followed up in the outpatient department after discharge until 3 years after surgery or until death or recurrence. Sample size calculation: In this study, the calculation of sample size was based on pre experiments and hypotheses, and a goodness test was conducted by selecting the means of two independent samples. Referring to the results of the pilot study, based on a 1:1 random (random number table method) ratio, assuming a significance level of unilateral α=0.025, a test power of 1- β=80%, and a superiority…
Sites
- The Affiliated Hospital of Qingdao UniversityShandong, Province, China
