Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial.
Song Zhao, Luyang Zhang, Feng Gao...
https://pubmed.ncbi.nlm.nih.gov/34613330Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07036588
Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial (PALARC 02)
Led by Third Military Medical University · Updated on 2025-06-25
968
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a modified transanal drainage tube (TDT) to prevent anastomotic leakage (AL) after low anterior resection in patients with rectal cancer. AL is a common complication that increases hospital stays, secondary surgeries, and mortality, while also raising the risk of cancer recurrence and reducing survival. This randomized clinical trial aims to compare the modified TDT, which allows postoperative irrigation and blocks feces from affecting the anastomosis, against no modified TDT to assess its effectiveness in reducing AL and related complications. Participants will be randomly assigned to either a group receiving the modified TDT or a group without it. All patients will undergo elective laparoscopic or robotic low anterior resection following colorectal cancer surgery guidelines, with surgeons deciding on additional procedures during surgery without bias from group assignment. The modified TDT is inserted after anastomosis completion and left in place for 7 days or until no longer functional. Both groups receive pelvic drainage, and surgeons follow standardized techniques to preserve arteries and assess the need for diverting stomas. During the study, participants will be monitored from surgery completion up to 30 days for AL incidence and grades, with follow-up extending to one year for anastomosis-related complications and up to three years for disease-free survival and local recurrence rates. Perianal pain will be assessed on postoperative days 1, 3, and 5. The study includes regular evaluations to track safety, effectiveness, and long-term outcomes related to the use of the modified drainage tube.
CONDITIONS
Brief Title
PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with rectal adenocarcinoma confirmed by pathology
- Tumor located 10 cm or less from the anal verge
- Age between 18 and 80 years old
- American Society of Anesthesiologists (ASA) score of 3 or less
- Assessed as suitable for laparoscopic or robotic sphincter-preserving surgery for rectal cancer
- Clinical stage T2-4N0-3M0 to T0-1N1-3M0 without local recurrence
- Signed informed consent form
- Able to understand the risks of participating in the trial
You will not qualify if you...
- Emergency surgery required
- Multiple primary colorectal cancers present
- History of long-term use of immunosuppressants or corticosteroids
- Severe mental illness or uncontrolled infection before surgery
- Pregnant or breastfeeding women
- Bowel obstruction before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Surgery day plus approximately 1 week
Participants undergo elective laparoscopic or robotic low anterior resection surgery. After the surgery, some participants receive a modified transanal drainage tube placed for up to 7 days to help prevent complications, while others do not receive this intervention. Surgeons decide on additional procedures during surgery based on individual patient assessment.
1 hospitalization visit including surgery and post-operative care
Post-operative Follow-up
Duration - Up to 3 years after surgery
Participants are monitored for anastomotic leakage and other surgery-related complications. Follow-up includes assessments up to 30 days after surgery, with ongoing monitoring for complications and cancer outcomes for up to 3 years after discharge.
Visits on postoperative days 1, 3, and 5; additional follow-up visits over months and years
Trial Site Locations
Total: 1 location
1
Army Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality, China, 400042
Actively Recruiting
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Research Team
Z
zhihao hu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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