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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07761169

Enrollment

Registered

2026-08-12

Start date

2026-08-30

Completion date

2030-09-30

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

PROCEDUREAI-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Mesorectal incomplete rate	2 weeks after surgery

Secondary

Measure	Time frame	Description
Operative conversion rate	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.
Positive resection margin rate	2 weeks after surgery	defined as the presence of cancer cells on the distal rectal resection margin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026