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

NCT07036588 | Recruiting

• 1 other identifier: TDT20250616
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anastomotic Leak

Outcome Measures

Primary Outcomes (1)

• Incidence of AL

  The incidence of total anastomotic leakage within 30 days after surgery

  The time frame is from the completion of the surgery to the 30th day after the surgery.

Secondary Outcomes (4)

• Grades of AL

  The time frame is from the completion of the surgery to the 30th day after the surgery.

• Incidence of anastomosis-related complications

  The time frame is from patient discharge to the 12th month after surgery.

• 3y-DFS AND LRR

  The time frame is from patient discharge to the third year after surgery.

• Perianal pain assessment score

  Measurement Time Points: Postoperative Day 1, Day 3, and Day 5

Study Arms (2)

mTDT Group

EXPERIMENTAL

Patients will undergo elective laparoscopic/robotic low anterior resection and will be subjected to a modified perianal drainage tube intervention.

Device: Modified Transanal Drainage Tube

Non-mTDT Group

NO INTERVENTION

Patients will undergo elective laparoscopic/robotic low anterior resection and will NOT be subjected to a modified perianal drainage tube intervention.

Interventions

Modified Transanal Drainage Tube DEVICE

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 affect the blood supply of the intestine). The external part of the tube will be sutured to the perianal skin and further secured with a 3M transparent dressing on the outside. It will be connected to a drainage bag (with an inner diameter greater than 8 mm) and left in place for 7 days, or until the drainage function is lost due to obvious defecation around the anal tube, at which point the catheter will be removed.

mTDT Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• WeiDong Tong

  Army Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhihao hu, MD

CONTACT

+8619144110767; hzhcm0802@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)