PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage

Official title

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

Overview

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

Detailed description

Patients were randomly assigned to two groups: the modified-TDT group and the non-modified-TDT group. Randomization was achieved using a computer-generated random number sequence allocation. To ensure all intraoperative decisions made by the surgeon remained unaffected by group assignment, surgeon allocation concealment was implemented : Surgeons were only informed of the group assignment and implemented the intervention according to the randomization result after completing the intestinal anastomosis and deciding whether to create a diverting stoma (DS) during the surgery. All surgical procedures strictly adhered to the guidelines for the diagnosis and treatment of colorectal cancer and the principles of total mesorectal excision (TME). Preservation of the left colic artery (LCA) was determined by the surgeon based on their experience and assessment of the patient's condition. Upon completion of the anastomosis, the surgeon decided on DS construction based on an assessment of risk factors for anastomotic leakage (AL). Pelvic drainage was utilized in all cases in this study.

Interventions

• Device Modified Transanal Drainage Tube
  Patients with rectal adenocarcinoma will undergo elective laparoscopic/robotic low anterior resection. After the anastomosis is completed and the air leak test is confirmed to be negative, a modified TDT (occlusive balloon catheter) will be inserted. The balloon will be placed 5 cm above the anastomosis and filled under laparoscopic visualization (approximately 25 ml) to slightly dilate the intestinal lumen and occlude the intestinal cavity (under laparoscopic monitoring to ensure it does not af

Primary outcome measures

• Incidence of AL [Time frame: The time frame is from the completion of the surgery to the 30th day after the surgery.]

Secondary outcome measures (4)

• Grades of AL [Time frame: The time frame is from the completion of the surgery to the 30th day after the surgery.]
• Incidence of anastomosis-related complications [Time frame: The time frame is from patient discharge to the 12th month after surgery.]
• 3y-DFS AND LRR [Time frame: The time frame is from patient discharge to the third year after surgery.]
• Perianal pain assessment score [Time frame: Measurement Time Points: Postoperative Day 1, Day 3, and Day 5]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Army Medical Center (Daping Hospital) — Yuzhong

Publications

• Zhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W. Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568. PMID 34613330

Identifiers

NCT: NCT07036588 · TDT20250616

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗