Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Rese… (NCT07241143) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Extra-Peritoneal Tunneling Versus Conventional Drain Fixation After Anterior or Low Anterior Resection
South Korea596 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients scheduled to undergo additional colonic resection (e.g., right hemicolectomy, transverse colectomy).
* Patients in whom no intraoperative drain placement is planned.
* 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.
* Patients with ASA physical status IV or severe systemic disease expected to require postoperative intensive care unit (ICU) admission.
* Patients who decline to provide informed consent for study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of successful conservative management in patients who developed an anastomotic leak
Timeframe: Within 60 days after diagnosis of anastomotic leak