Flushing the rectum during laparoscopic surgery to lower the chance of cancer coming back after mid-to-low rectal cancer removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.