Flushing the rectum during laparoscopic surgery to lower the chance of cancer coming back after mid-to-low rectal cancer removal
Laparoscopic Rectal Irrigation for the Prevention of Local Recurrence After Radical Resection of Mid-to-Low Rectal Cancer: A Prospective, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Study
This will test whether flushing the rectum during laparoscopic removal of mid-to-low rectal cancer lowers the chance the cancer comes back near the original site.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1598 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07512232 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, open-label, multicenter parallel trial comparing standard laparoscopic sphincter-preserving radical resection with or without intraoperative rectal lavage. About 1,598 patients with mid-to-low rectal adenocarcinoma (tumor ≤10 cm from the anal verge) will be randomized and followed for up to 60 months for local recurrence, overall survival, postoperative complications, and quality of life. The primary outcome is postoperative local recurrence rate; secondary outcomes include overall survival, anastomotic leak and stenosis rates, and EORTC QLQ-C30 measured at 6 months. The trial is based on the rationale that mechanical or cytotoxic flushing may remove exfoliated tumor cells that could seed an anastomosis during surgery.
Who should consider this trial
Good fit: Adults aged 18–75 with pathologically confirmed mid-to-low rectal adenocarcinoma (tumor lower margin ≤10 cm from the anal verge) scheduled for laparoscopic sphincter-preserving radical resection are ideal candidates.
Not a fit: Patients who require non-sphincter-preserving operations (abdominoperineal or Hartmann's procedures), those undergoing emergency obstruction surgery, or patients with severe comorbidities are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, rectal lavage could lower rates of local recurrence after surgery and thereby improve long-term outcomes and quality of life.
How similar studies have performed: Some observational reports and small trials have suggested rectal lavage may reduce intraluminal tumor cells and local recurrence risk, but high-quality multicenter randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years old. * Pathologically confirmed rectal adenocarcinoma. * Mid-to-low rectal cancer with the tumor lower margin located ≤10 cm from the anal verge. * Underwent laparoscopic radical resection for rectal cancer with sphincter preservation. * Without concomitant multiple primary malignancies. * Adequate organ function. * Patients or their family members were able to understand the study protocol, willing to participate in this study, and provided written informed consent. Exclusion Criteria: * Concomitant other malignancies or a history of prior malignancies. * Abdominal perineal resection (Miles' operation) or Hartmann's procedure. * Failure to open the peritoneal reflection during surgery. * History of previous pelvic floor surgery. * Emergency surgery due to bowel obstruction. * Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure. * History of severe psychiatric disorders. * Pregnant or lactating women. * Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.
Where this trial is running
Guangzhou, Guangdong
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Liang Huang, Doctor
- Email: huangl75@sysu.edu.cn
- Phone: +86 15989101216
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.