Clinical trial · Interventional
Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer
NCT07761169CI-TRIAL-00121562not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted decision-making | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- 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.
- interventionNames
- Procedure: AI-assisted decision-making
- type
- NO_INTERVENTION
- label
- control group
- description
- The surgeon selects the surgical approach and performs the procedure
Primary outcomes (1)
- measure
- Mesorectal incomplete rate
- timeFrame
- 2 weeks after surgery
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.