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

NCT07512232 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1598

Last updated 2026-04-06

No results posted yet for this study

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).

Conditions

  • Middle and Low Rectal Cancer
  • Rectal Cancer Surgery

Interventions

PROCEDURE

Rectal irrigation

Laparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07512232 on ClinicalTrials.gov