Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer, Sigmoid Colon Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.85 |
| Rectal Diseases, Sigmoid Colon Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional drain insertion | Procedure | — | UNRESOLVED |
| EPT drain fixation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional drain insertion
- description
- Participants undergo standard transperitoneal pelvic drain placement following anterior or low anterior resection.
- interventionNames
- Procedure: Conventional drain insertion
- type
- EXPERIMENTAL
- label
- EPT drain fixation
- description
- Participants undergo pelvic drain placement using the extra-peritoneal tunneling (EPT) method following anterior or low anterior resection.
- interventionNames
- Procedure: EPT drain fixation
Primary outcomes (1)
- measure
- Rate of successful conservative management in patients who developed an anastomotic leak
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available