Clinical trial · Interventional
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
The Impact of Transanal Decompression Tube Placement on Anastomotic Dehiscence After Colorectal Anastomosis. A Randomized and Controlled Clinical 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)
There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Complication | — | UNRESOLVED | — |
| Anastomotic Leak | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative transanal decompression tube placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraoperative transanal decompression tube placement
- description
- Intraoperatively under direct vision in the lower rectum, the balloon of the catheter will be inflated with 5-10cc of distilled water and it will be secured with a dressing / tape to the buttock connected to a collection bag.
- interventionNames
- Procedure: Intraoperative transanal decompression tube placement
- type
- NO_INTERVENTION
- label
- Non intraoperative transanal decompression tube placement
- description
- The usual postoperative care approved by the unit will be followed.
Primary outcomes (1)
- measure
- Anastomotic leakage rate between treatment arms
- timeFrame
- Within 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing scheduled laparoscopic, robotic or laparotomic colorectal cancer surgery who undergo colorectal anastomosis. * Both mechanical and manual colorectal anastomosis with or without diverting ileostomy. * Negative intraoperative air-leak test. * Height of the anastomosis: promontory or distal to it. * Age≥18 years. * Histology of Adenocarcinoma with or without prior neoadjuvant treatment. * Any T, any N, any M. * Informed consent signed by the patient and by the researcher. Exclusion Criteria: * No performance of colorectal anastomosis. * Colorectal tumor with histology other than adenocarcinoma or adenoma. * Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of surgery. * Inability to read or understand any of the informed consent languages (Catalan, Spanish). * Emergency surgery. * Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
References
Publications (0)
Data not yet available