Clinical trial · Interventional
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection
A Novel Adaptive Anastomotic Technique for Left-sided Colonic and Rectal Resection: a Pilot, Single-center, Prospective, Case-series Study
NCT06481605CI-TRIAL-00078416NOVAunknownN/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)
The C-REX device is design to help colorectal anastomoses construction and reduce the risk of anastomotic leak. This study aims to collect preliminary evidence on the effectiveness of C-REX a real-word setting.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-REX | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-REX
- description
- Patients will receive the C-REX device during anastomosis construction
- interventionNames
- Device: C-REX
Primary outcomes (1)
- measure
- Radiological anastomotic leaks
- timeFrame
- 90 days after surgery
- description
- Assess the rate of radiologically confirmed anastomotic leak in the C-REX arm
Secondary outcomes (9)
- measure
- Severity of anastomotic leaks
- timeFrame
- 90 days after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years old, men or women. * Planned primary resection due to colorectal neoplasia (cancer or benign polyps) of the sigmoid colon or rectum (above the peritoneal reflection) that require high anterior resection as the procedure of choice. * Patient indicated to elective minimally invasive sigmoid or high rectal resection. Exclusion Criteria: * Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. * Patients with preoperative evidence of distal metastasis. * Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. * Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition. * Patients indicated to defunctioning ileostomy (intention to treat). * Any condition that, in the opinion of the investigator, may interfere with the study conduction. In particular, any condition which can cause significant alteration of colonic wall thickness such as chronic and repeated infection which may impair the use of C-REX.
References
Publications (0)
Data not yet available
No reference posted for this study.