NCT07761169

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
50mo left

Started Aug 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

August 30, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Mesorectal incomplete rate

    2 weeks after surgery

Secondary Outcomes (2)

  • Operative conversion rate

    during the surgery

  • Positive resection margin rate

    2 weeks after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

The surgeon selects the surgical approach and performs the procedure

Interventions

AI-assisted decision-makingPROCEDURE

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

experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xiao Yi

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 30, 2030

Last Updated

August 12, 2026

Record last verified: 2026-08