NCT06814093Active, not recruiting
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2702 (actual)
- First submitted
- 3 Feb 2025
- Start date
- 1 Jan 2021
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Xu jianmin
- Diseases
- Colorectal cancer
- NCT number
- NCT06814093
What you commit to
- Study type: Observational
- Participants enrolled: 2702
- From 1 Jan 2021 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Synchronous colon surgery for multiple colorectal tumors or other schedules;
- Patients received treatment other than preoperative radio- or chemoradiotherapy.
Other illness
- Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
- Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
- Co-existent inflammatory bowel disease;
Other
- Pregnancy or lactation;
Who the study is looking for
- Age from 18 years to 80 years;
- American Society of Anesthesiologists (ASA) class I - III;
- Histologically proved rectal adenocarcinoma;
- Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
- Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
- No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;
- No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
- Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;
- 10\) Informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital, Fudan University, Shanghai, China Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.