Colorectal Cancer Clinical Trials

Find Colorectal Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Army Medical Center (Daping Hospital)
RECRUITING
Yuzhong
Contact Information
Primary
zhihao hu, MD
hzhcm0802@163.com
+8619144110767
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 968
Treatments
Experimental: mTDT Group
Patients will undergo elective laparoscopic/robotic low anterior resection and will be subjected to a modified perianal drainage tube intervention.
No_intervention: Non-mTDT Group
Patients will undergo elective laparoscopic/robotic low anterior resection and will NOT be subjected to a modified perianal drainage tube intervention.
Related Therapeutic Areas
Sponsors
Leads: Third Military Medical University

This content was sourced from clinicaltrials.gov