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

Not Applicable

Recruiting

• Conditions: Anastomotic Leak

• Registration Number: NCT07036588
• Lead Sponsor: Third Military Medical University

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

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-01
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 968

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of AL	The time frame is from the completion of the surgery to the 30th day after the surgery.	The incidence of total anastomotic leakage within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Grades of AL	The time frame is from the completion of the surgery to the 30th day after the surgery.	Classification of anastomotic leakage: Grade A is asymptomatic and detected by imaging only; Grade B requires specific interventions but not surgical treatment; Grade C requires surgical treatment.
Incidence of anastomosis-related complications	The time frame is from patient discharge to the 12th month after surgery.	The overall incidence of anastomosis-related complications within 12 months after surgery.
3y-DFS AND LRR	The time frame is from patient discharge to the third year after surgery.	Three-year disease-free survival (DFS) and local recurrence rate.
Perianal pain assessment score	Measurement Time Points: Postoperative Day 1, Day 3, and Day 5	Numerical Rating Scale (NRS) \[0-10 scale\]: No pain (0); Mild pain (1-3); Moderate pain (4-6); Severe pain (7-10)

Trial Locations

Locations (1)

Army Medical Center (Daping Hospital); 🇨🇳 Yuzhong, Chongqing, China

Army Medical Center (Daping Hospital)

🇨🇳Yuzhong, Chongqing, China

Weidong Tong, MD

Contact

02368729356

vdtong@163.com