Modified surgery for ultralow rectal cancer
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study
This study is testing a new type of surgery for people with ultralow rectal cancer to see if it can help them keep better anal function and have fewer complications compared to traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05245565 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of modified precision functional sphincter-preserving surgery (PPS) on patients with ultralow rectal cancer. It will collect data from patients undergoing sphincter-preserving surgeries, comparing the outcomes of modified PPS with conventional surgical methods. The focus is on minimizing surgical trauma, preserving anal function, and reducing complications such as anastomotic leakage. The study seeks to improve the quality of life for patients by assessing the efficacy and safety of the modified surgical approach.
Who should consider this trial
Good fit: Ideal candidates include patients with newly diagnosed primary adenocarcinoma of the rectum, with tumors located within 3 cm of the dentate line and clinical T stage ≤ T3.
Not a fit: Patients with locally advanced tumors, metastatic disease, or those with impaired anal function prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with ultralow rectal cancer.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in improving surgical outcomes for rectal cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum 2. The lower edge of tumor \< 3 cm from the dentate line 3. Clinical T stage ≤ T3 Exclusion Criteria: 1. The lower edge of tumor \< 1 cm from the dentate line 2. Locally advanced stage of tumor 3. Presence of metastatic disease or recurrent rectal tumor 4. Concomitant malignancies 5. Concurrent uncontrolled medical conditions 6. Impaired anal function before surgery 7. Presence of acute bowel obstruction or bowel perforation caused by cancer 8. Pregnancy or breast feeding
Where this trial is running
Shanghai, Shanghai
- Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Cheng-Le Zhuang, MD, PhD
- Email: zhuangchengle@tongji.edu.cn
- Phone: +86-19921618250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.