NCT07512232 Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
| NCT ID | NCT07512232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Middle and Low Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,598 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,598 participants in total. It began in 2025-06-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07512232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Middle and Low Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07512232 currently recruiting?
Yes, NCT07512232 is actively recruiting participants. Contact the research team at huangl75@sysu.edu.cn for enrollment information.
Where is the NCT07512232 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07512232 clinical trial?
NCT07512232 is sponsored by Sun Yat-sen University. The trial plans to enroll 1,598 participants.
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