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

ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-assisted decision-making

    Procedure/Surgery

    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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mesorectal incomplete rate

Time frame
2 weeks after surgery

Secondary outcomes

1

Operative conversion rate

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.

Time frame
during the surgery
2

Positive resection margin rate

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

Time frame
2 weeks after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: