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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Rectal irrigation

Treatment groups

1,598 Participants
are divided into 2 treatment groups

Sponsors and collaborators