Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07761169

Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer

This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.

Not Yet Recruiting

Trial opening soon.

Get Notified

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

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathological examination confirmed a diagnosis of rectal adenocarcinoma; radical surgery is recommended.
  • The inferior border of the tumor is ≥1 cm from the dentate line and ≤7 cm from the anal verge;
  • Preoperative staging was assessed in a stage of c/ycT1-3N0-2M0;
  • The cardiac, pulmonary, hepatic, renal, and other organ functions are adequate, and the patient can tolerate laparoscopic surgery.

Exclusion criteria

  • Intraoperative exploration is unable to achieve R0 resection or preservation of the anus;
  • Lateral lymph node dissection is required;
  • Patients with a history of severe mental illness, immune disorders, or those taking hormonal medications;
  • Any other circumstances in which the investigator deems it inappropriate for inclusion.

Treatment and study plan

AI-assisted decision-making

Procedure

The SurgDiff model performs a difficulty assessment based on the patient's preoperative MRI scans and clinical data, thereby assisting the surgeon in formulating the surgical plan

Primary outcomes

  1. Mesorectal incomplete rate

    Time frame: 2 weeks after surgery

Secondary outcomes

  1. Operative conversion rate

    Time frame: during the surgery

    Defined as the proportion of cases where laparoscopic total mesoresection (laTME) was converted to open total mesoresection (taTME), or where taTME was converted back to laTME, or where conversion occurred to an open surgical approach during the procedure.

  2. Positive resection margin rate

    Time frame: 2 weeks after surgery

    defined as the presence of cancer cells on the distal rectal resection margin

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.