Clinical Trial

Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial

Study acronym: TOWER-2
Recruiting
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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).
Trial Details
NCT Number NCT07512232
Lead Sponsor Sun Yat-sen University
Conditions Middle and Low Rectal Cancer, Rectal Cancer Surgery
Enrollment 1,598 participants
Start Date 2025-06-01
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-06