Comparing robotic and laparoscopic surgery for rectal cancer recovery
Study on Clinical Application of Robotic Technique
This study is testing whether robotic surgery for rectal cancer can help patients recover better and have fewer problems with bladder and sexual function compared to traditional laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06409403 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of robotic-assisted total mesorectal excision (R-TME) versus traditional laparoscopic total mesorectal excision (L-TME) on genitourinary function in patients with rectal cancer. The focus is on minimizing pelvic autonomic nerve injury during surgery, which is a common cause of postoperative genitourinary dysfunction. By utilizing advanced robotic technology, the study aims to enhance the surgeon's ability to identify and preserve critical nerves during the procedure. The study will include patients aged 18 to 75 with specific eligibility criteria related to their cancer stage and overall health.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 75 with rectal cancer who meet specific health criteria and have no severe comorbidities.
Not a fit: Patients with benign prostate hyperplasia, previous bladder or prostate surgeries, or severe sexual dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery of genitourinary function for patients undergoing surgery for rectal cancer.
How similar studies have performed: Previous studies have indicated potential benefits of robotic surgery in improving postoperative functions, but this specific comparison is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3 Exclusion Criteria: Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score \<10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.
Where this trial is running
Changsha, Hunan
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Bo Yi, MD
- Email: yibo2018pro@126.com
- Phone: 13786179533
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.