Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
Recruiting · NCT07512232 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Emergency surgery due to bowel obstruction.
- Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure.
- History of severe psychiatric disorders.
- Pregnant or lactating women.
- Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.
Where it is running
1 location listed.
- Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China