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).
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.
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.
Parallel
Rectal irrigation
Procedure/SurgeryLaparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine
Postoperative local recurrence rate
The postoperative local recurrence rate following laparoscopic radical resection for mid-to-low rectal cancer is defined as the number of patients with recurrence divided by the total number of subjects.
Postoperative overall survival
Postoperative Overall Survival (OS) is defined as the length of time from the date of surgery to the date of death from any cause.
Postoperative complications
Postoperative complications-including anastomotic leakage, pelvic infection, surgical site infection, intra-abdominal hemorrhage, urinary tract infection, etc.-were graded according to the Clavien-Dindo classification system.
Health-related quality of life at 6 months
Health-related quality of life at 6 months postoperatively was assessed using the EORTC QLQ-C30 questionnaire.
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