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New treatment option for Middle and Low Rectal Cancer
Official title Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
ClinicalTrials.gov ID: NCT07512232
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.