Modified transanal drainage tube to prevent anastomotic leaks after rectal cancer surgery

Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial(PALARC 02)

This trial tests whether placing a modified transanal drainage tube can reduce anastomotic leakage in adults having sphincter-preserving rectal cancer surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 968 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Yuzhong, Chongqing Municipality)
• Trial ID: NCT07036588 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial assigns patients undergoing laparoscopic or robotic sphincter-preserving rectal cancer surgery to either a modified transanal drainage tube that allows postoperative irrigation or to a non-modified approach. Randomization is computer-generated and surgeons are informed of group assignment only after completing the anastomosis to avoid influencing intraoperative decisions, with pelvic drains used in all cases. Surgical treatment follows total mesorectal excision principles with selective preservation of the left colic artery and selective diverting stoma based on intraoperative risk assessment. Primary outcomes include the incidence of anastomotic leakage, need for reoperation, and short-term postoperative recovery metrics.

Who should consider this trial

Good fit: Adults 18–80 years old with pathologically confirmed rectal adenocarcinoma whose lower tumor edge is ≤10 cm from the anal verge, ASA ≤3, and who are candidates for laparoscopic or robotic sphincter-preserving surgery.

Not a fit: Patients undergoing emergency surgery, those with bowel obstruction, multiple primary colorectal cancers, long-term immunosuppression or uncontrolled infection, pregnant or breastfeeding women, or those not eligible for sphincter-preserving surgery are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the modified tube could lower anastomotic leak rates, reduce reoperations and hospital stays, and improve short- and long-term outcomes after rectal cancer surgery.

How similar studies have performed: Prior research showed traditional transanal drainage tubes did not reliably prevent leaks, so the modified irrigatable TDT approach is relatively novel with limited prior evidence of benefit.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Yuzhong, Chongqing Municipality

• Army Medical Center (Daping Hospital) — Yuzhong, Chongqing Municipality, China (Recruiting)

Study contacts

• Principal investigator: WeiDong Tong — Army Medical University, China
• Study coordinator: zhihao hu, MD

Conditions Anastomotic Leak