PPISR for low- to mid-rectal cancer with anus-sparing aim
Official title: Application of Precision Partial Intersphincteric Resection (PPISR) in Patients With Ultra-low Rectal Cancer
Run by First Affiliated Hospital of Wenzhou Medical University · NCT07849023 · Data updated 2026-11-12
This study tests whether Precision Partial Intersphincteric Resection can be safely used to remove certain rectal cancers while preserving the anus.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Status | Recruiting |
| Started | February 8, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2030 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07849023 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with lower-rectal or rectal cancer meeting specific tumor distance, staging, and health criteria, suitable for anus-preserving surgery.
✕Probably not a fit
Patients with extensive disease, poor baseline anal function, or contraindicating conditions may not benefit from PPISR.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares Precision Partial Intersphincteric Resection (PPISR) with traditional intersphincteric resection in adults with lower-rectal adenocarcinoma. It aims to establish a standardized surgical procedure and to evaluate safety, functional outcomes, and cancer control. Eligible participants have tumors close to the anal verge, no distant metastasis, and suitable rectal cancer pathology. The study is conducted at the First Affiliated Hospital of Wenzhou Medical University. Enrollment criteria exclude patients with significant comorbidities, other malignancies, emergency indications, or poor baseline anal function.
Why it matters
Potential benefit: If successful, patients may retain better anal function and have effective cancer control after PPISR.
How similar studies have gone: Previous surgical approaches with sphincter-preserving techniques have shown promise in select patients, but PPISR is being evaluated for standardized procedures and broader safety/efficacy data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-75 years old * Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma * Tumor lower margin ≤ 5 cm from the anal verge * Pre-operative tumor (T) staging of T1-T3 and T1-T2 below the level of the anal raphe muscle * No distant metastasis such as lung, liver and other organs Exclusion Criteria: * Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.) * Patients with malignant tumors in other parts of the body * Patients who underwent emergency surgery due to acute perforation, obstruction, etc. * Patients with tumor infiltration of peripheral organs during the operation, which required combined resection or palliative resection * Patients who had a mid-opening laparoscopic operation for various reasons -during the operation * Patients with poor anal function before operation, which is not suitable for anus preservation surgery.
Where it's running
-
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: shaotang li
- Email: lishaotang163@163.com
- Phone: 86+18815039766
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.