NCT07241143Not yet recruiting
Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Resection
Comparison of the Efficacy and Safety of Extra-Peritoneal Tunneling Drain Fixation Versus Conventional Drain Insertion Following Anterior or Low Anterior Resection (ExPeTuD Trial): A Multi-Center Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
The goal of this clinical trial is to learn whether the extra-peritoneal tunneling (EPT) drain fixation method works better and more safely than the conventional drain insertion method after rectal cancer surgery. It will also learn about the safety and possible complications of the EPT technique. The main questions it aims to answer are: Does the EPT drain fixation method increase the success rate of conservative management (drain maintenance and/or antibiotics) when an anastomotic leak occurs? Does the EPT method reduce the rate of drain displacement compared with the conventional method? Are there any safety concerns or complications associated with the EPT method? Researchers will compare EPT drain fixation to the conventional drain method to see which approach provides better outcomes after anterior or low anterior resection for rectal cancer. Participants will: Undergo anterior or low anterior resection for rectal cancer as part of their standard surgical treatment. Be randomly assigned to either the EPT drain fixation group or the conventional drain group. Receive the same postoperative care as usual, including follow-up imaging to monitor drain position and recovery. Be observed for postoperative outcomes such as anastomotic leakage, drain position, and related complications until recovery. This study will help determine whether securing the drain through an extra-peritoneal tunnel can prevent drain movement, improve early management of leakage, and enhance patient recovery after rectal surgery.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 596 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Yeungnam University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07241143
What you commit to
- Study type: Interventional
- Planned participants: 596
- From 1 Dec 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy).
- Patients scheduled for permanent or end stoma formation (e.g., abdominoperineal resection or Hartmann's procedure).
- Patients with prior pelvic surgery (e.g., hysterectomy, prostatectomy, pelvic lymph node dissection) that may cause pelvic adhesions or anatomic distortion.
Other illness
- Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission.
Other
- Patients in whom no intraoperative drain placement is planned.
- Patients who decline to provide informed consent for study participation
Who the study is looking for
- Patients scheduled to undergo rectal resection (anterior resection or low anterior resection) with planned intraoperative drain placement.
- Expected anastomotic level ≤10 cm from the anal verge based on preoperative imaging or endoscopic evaluation.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sung Il Kang Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.