Clinical trial NCT06814093: Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
Official title: Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 2702
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data is sourced from the Colorectal Cancer Specialty Cohort Database and Biobank, established through the "Construction and Application of the Shanghai Colorectal Cancer Specialty Cohort Database and Biobank" project. The research will utilize cohort data collected from January 2021 to May 2022 (17 months). This specialized database was led by Zhongshan Hospital, Fudan University, in collaboration with Shanghai Tenth People's Hospital, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Naval Medical University (Changhai Hospital), Renji Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai First People's Hospital.

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1. Age from 18 years to 80 years;
2. American Society of Anesthesiologists (ASA) class I - III;
3. Histologically proved rectal adenocarcinoma;
4. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
5. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
6. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;
7. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
8. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;

10) Informed consent.

Exclusion criteria

1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
2. Synchronous colon surgery for multiple colorectal tumors or other schedules;
3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
4. Co-existent inflammatory bowel disease;
5. Pregnancy or lactation;
6. Patients received treatment other than preoperative radio- or chemoradiotherapy.

Primary outcomes:
measure: 3-year postoperative disease-free survival rate
timeFrame: From surgery to three years postoperatively
Secondary outcomes:
measure: Circumferential resection margin positivity rate
timeFrame: 14 days during postoperative pathological examination
measure: 30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)
timeFrame: From surgery to 30 days postoperatively
measure: rate of abdominoperineal resection
timeFrame: 30 days after surgery
measure: 3-year postoperative locoregional recurrence rate
timeFrame: From surgery to three years postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
References: