Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Can… (NCT07512232) | Clinical Trial Compass
RecruitingNot Applicable
Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
China1,598 participantsStarted 2025-06-01
Plain-language summary
Brief Summaries Trial Purpose The primary objective of this prospective, randomized, multicenter, open-label, parallel-controlled clinical trial is to evaluate whether intraoperative rectal irrigation during laparoscopic radical resection of low-to-mid rectal cancer reduces postoperative local recurrence rates compared to no irrigation. Secondary objectives include assessing overall survival, incidence of postoperative complications (e.g., anastomotic leakage, stenosis), and quality of life at 6 months (EORTC QLQ-C30 scale).
Participants Will:
* Undergo laparoscopic radical resection with or without rectal irrigation (based on randomization);
* Follow standardized Enhanced Recovery After Surgery (ERAS) protocols postoperatively;
* Attend scheduled follow-ups at 3, 6, 12, 24, 36, and 60 months post-surgery, including clinical evaluations, imaging (CT/MRI), laboratory tests (CEA), and questionnaire assessments;
* Maintain a symptom diary and record rescue inhaler usage (if applicable).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative local recurrence rate
Timeframe: Within 3 years after radical resection of rectal cancer