PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage
Recruiting now · Not applicable
Conditions studied: Anastomotic Leak
In brief
Surgical resection remains the primary treatment for rectal cancer, but the postoperative incidence of anastomotic leakage (AL) is relatively high. AL not only increases the medical burden on patients, prolongs hospital stays, raises the need for secondary surgery, and elevates perioperative mortality, but also increases the long-term risk of local recurrence and reduces survival rates. There is an urgent need for a simple, effective treatment method that minimizes the burden on patients to prevent anastomotic leakage. The preoperative placement of a transanal drainage tube (TDT) is believed to effectively drain gas and feces from the intestinal lumen, thereby reducing intestinal pressure and alleviating tension at the anastomotic site, thus preventing AL. Previous studies have shown that traditional drainage tubes cannot effectively prevent leakage. Given the limitations of existing research on traditional TDTs, we plan to use a modified TDT (which allows postoperative irrigation and utilizes a balloon to block feces from adversely affecting the anastomosis) to conduct a randomized, parallel-controlled trial. This study aims to further investigate the role of the modified TDT in preventing and treating anastomotic leakage following rectal surgery
Key facts
- Study ID
- NCT07036588
- Run by
- Third Military Medical University
- People needed
- 968
- Starts
- 2025-07-01
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-06-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Rectal adenocarcinoma (confirmed by pathology);
- Tumor location: The lower edge is ≤10 cm from the anal verge;
- Age: ≥18 and ≤80 years old;
- ASA ≤3 ;
- After assessment, laparoscopic/robotic sphincter - preserving surgery for rectal cancer is feasible;
- T2 - 4N0 - 3M0\~T0 - 1N1 - 3M0 \& non- local recurrence;
- Signed informed consent form;
- Able to understand the risks of participating in the trial.
You may not qualify if…
- Emergency surgery;
- Presence of multiple primary colorectal cancers;
- History of long - term use of immunosuppressants or corticosteroids;
- Patients with severe mental illness or uncontrolled infection before surgery;
- Pregnant or breastfeeding women;
- Bowel obstruction before surgery.
Where it is running
- Army Medical Center (Daping Hospital) — Yuzhong, Chongqing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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