Modified transanal drainage tube to prevent anastomotic leaks after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial assigns patients undergoing laparoscopic or robotic sphincter-preserving rectal cancer surgery to either a modified transanal drainage tube that allows postoperative irrigation or to a non-modified approach. Randomization is computer-generated and surgeons are informed of group assignment only after completing the anastomosis to avoid influencing intraoperative decisions, with pelvic drains used in all cases. Surgical treatment follows total mesorectal excision principles with selective preservation of the left colic artery and selective diverting stoma based on intraoperative risk assessment. Primary outcomes include the incidence of anastomotic leakage, need for reoperation, and short-term postoperative recovery metrics.

Why it matters

Who can join: the full rules

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

Where it's running

• Army Medical Center (Daping Hospital)
  Yuzhong, Chongqing Municipality, China Recruiting

Study contacts

• Principal investigator: WeiDong Tong — Army Medical University, China
• Study coordinator: zhihao hu, MD
• Email: hzhcm0802@163.com
• Phone: +8619144110767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.