Clinical trial · Interventional
Mucosal Flap Reinforced Colorectal Anastomosis and Trans-Anal Vacuum Drainage: A Feasibility Study
Low Anterior Resection Combined With Transanal Reinforcement and Endoluminal Sponge Vacuum Drainage
NCT04735107CI-TRIAL-00049776EndodrainunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Background: Dehiscence of colorectal anastomosis is a serious complication associated with increased mortality and impaired functional and oncological outcomes. We hypothesised that anastomosis reinforcement and vacuum trans-anal drainage could eliminate some risk factors of colorectal anastomotic dehiscence,including mechanically stapled anastomosis instability and local infection.
Conditions
Conditions (1)
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 | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colorectal anastomosis reinforcement and trans-anal drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reinforcement
- description
- Low anterior resection + mucosa flap reinforcement + vacuum sponge endoluminal drainage
- interventionNames
- Procedure: colorectal anastomosis reinforcement and trans-anal drainage
Primary outcomes (2)
- measure
- Incidence of anastomotic leak
- timeFrame
- 30 days
- description
- Leak of colorectal anastomosis proven by endoscopy/or/and computed tomography
- measure
- Defunction ileostomy rate
- timeFrame
- 30 days
- description
- Rate of fecal diversion in group of treated patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosed extraperitoneal rectal cancer, cT1-cT4 * Patient with low anterior resection and double-stapled anastomosis technique Exclusion Criteria: * Patients not provided written informed consent * Patients with cT4: with pelvic side wall involement, requiring pelvic more extensive procedure * Patients with recurrent rectal cancer
References
Publications (1)
- DERIVEDFerko A, Vana J, Adamik M, Svec A, Zacek M, Demeter M, Grendar M. Mucosa plication reinforced colorectal anastomosis and trans-anal vacuum drainage: a pilot study with preliminary results. Updates Surg. 2021 Dec;73(6):2145-2154. doi: 10.1007/s13304-021-01105-4. Epub 2021 Jun 5. PMID 34089500