NCT07036588 PARLAR-02 Trial：Modified Transanal Drainage Tube Use for Preventing Anastomotic Leakage
| NCT ID | NCT07036588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Third Military Medical University |
| Condition | Anastomotic Leak |
| Study Type | INTERVENTIONAL |
| Enrollment | 968 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 968 participants in total. It began in 2025-07-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 - 2M0\~T0 - 1N1 - 2M0 \& 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； * BMI ≥35.0
Contact & Investigator
WeiDong Tong
PRINCIPAL INVESTIGATOR
Army Medical University, China
Frequently Asked Questions
Who can join the NCT07036588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Anastomotic Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036588 currently recruiting?
Yes, NCT07036588 is actively recruiting participants. Contact the research team at hzhcm0802@163.com for enrollment information.
Where is the NCT07036588 trial being conducted?
This trial is being conducted at Yuzhong, China.
Who is sponsoring the NCT07036588 clinical trial?
NCT07036588 is sponsored by Third Military Medical University. The principal investigator is WeiDong Tong at Army Medical University, China. The trial plans to enroll 968 participants.