NCT07512232Recruiting
Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
Laparoscopic Rectal Irrigation for the Prevention of Local Recurrence After Radical Resection of Mid-to-Low Rectal Cancer: A Prospective, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1598 (estimated)
- First submitted
- 30 Mar 2026
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07512232
What you commit to
- Study type: Interventional
- Planned participants: 1598
- From 1 Jun 2025 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abdominal perineal resection (Miles' operation) or Hartmann's procedure.
- History of previous pelvic floor surgery.
- Emergency surgery due to bowel obstruction.
Other illness
- Concomitant other malignancies or a history of prior malignancies.
- Failure to open the peritoneal reflection during surgery.
- History of severe psychiatric disorders.
Lab values
- Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.
Other
- Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure.
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.