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

August 7, 2026 updated by: XIAO Yi, MD, Peking Union Medical College Hospital
This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
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.
Procedure: AI-assisted decision-making
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
No Intervention: control group
The surgeon selects the surgical approach and performs the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mesorectal incomplete rate
Time Frame: 2 weeks after surgery
2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the surgery
Positive resection margin rate
Time Frame: 2 weeks after surgery
defined as the presence of cancer cells on the distal rectal resection margin
2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

August 7, 2026

First Submitted That Met QC Criteria

August 7, 2026

First Posted (Actual)

August 12, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SurgDiff-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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