An interventional study of Modified Transanal Drainage Tube in Anastomotic Leak, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Prevention
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
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.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 968 is above the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients will undergo elective laparoscopic/robotic low anterior resection and will NOT be subjected to a modified perianal drainage tube intervention.
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.
Incidence of AL
The incidence of total anastomotic leakage within 30 days after surgery
Time frame: The time frame is from the completion of the surgery to the 30th day after the surgery.
Grades of AL
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.
Time frame: The time frame is from the completion of the surgery to the 30th day after the surgery.
Incidence of anastomosis-related complications
The overall incidence of anastomosis-related complications within 12 months after surgery.
Time frame: The time frame is from patient discharge to the 12th month after surgery.
3y-DFS AND LRR
Three-year disease-free survival (DFS) and local recurrence rate.
Time frame: The time frame is from patient discharge to the third year after surgery.
Perianal pain assessment score
Numerical Rating Scale (NRS) \[0-10 scale\]: No pain (0); Mild pain (1-3); Moderate pain (4-6); Severe pain (7-10)
Time frame: Measurement Time Points: Postoperative Day 1, Day 3, and Day 5
Plan to share: No
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Third Military Medical University