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NCT Number: NCT06814093

Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Informed consent.

Exclusion criteria

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

Treatment and study plan

Robotic surgery

Procedure

Robotic surgery for radical resection of middle and low rectal cancer

Laparoscopic surgery

Procedure

Laparoscopic surgery for radical resection of middle and low rectal cancer

Primary outcomes

  1. 3-year postoperative disease-free survival rate

    Time frame: From surgery to three years postoperatively

    Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.

Secondary outcomes

  1. Circumferential resection margin positivity rate

    Time frame: 14 days during postoperative pathological examination

    Circumferential resection margin positivity is defined as 1 mm or less from the tumor.

  2. 30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)

    Time frame: From surgery to 30 days postoperatively

    30-day postoperative complication rate is defined according to the Clavien-Dindo grade system. Only complications in grade 2 or higher grade will be calculated.

  3. rate of abdominoperineal resection

    Time frame: 30 days after surgery

    percentage of patients received abdominoperineal resection

  4. 3-year postoperative locoregional recurrence rate

    Time frame: From surgery to three years postoperatively

    Locoregional recurrence is defined as any cancer recurrence in the pelvic or perineal area.

Sponsors and collaborators

Lead sponsor

Xu jianmin

Other

Registry information

Official study title

Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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