Clinical trial · Interventional
Electric Tubular Anastomosis in Rectal Cancer
Application of Electric Tubular Anastomotic Device in Colorectal Tumor Surgery: a Multi-center 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)
Compared with traditional manual suturing, mechanical anastomosis can reduce the error caused by human factors. The electric anastomotic device can improve the automation and accuracy of anastomosis, reduce the requirements for doctors' operation, and establish a more standardized usage specification, thereby reducing the surgical complication rate and improving the quality of anastomosis. The clinical study of electric tubular anastomotic device adopts a multicenter, randomized, parallel controlled non-inferior study design, and randomly groups according to the 1:1 ratio to evaluate the clinical effectiveness and safety of electric tubular anastomotic device compared with conventional manual device.
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 |
|---|---|---|---|
| Anastomosis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| electric tubular anastomotic device | Device | — | UNRESOLVED |
| traditional anastomotic device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- traditional anastomotic device
- interventionNames
- Device: traditional anastomotic device
- type
- EXPERIMENTAL
- label
- electric tubular anastomotic device
- interventionNames
- Device: electric tubular anastomotic device
Primary outcomes (1)
- measure
- success rate of anastomosis
- timeFrame
- 1 week after surgery
- description
- The end-to-end and end-to-side anastomosis of the intestinal tissue is performed during the operation. After the performance of anastomosis, the instrument is withdrawn. The anastomosis should be checked of accuracy, completeness and bleeding.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-80y; * Patients with resectable rectal cancer who are scheduled to undergo Dixon surgery (definition of rectal cancer: the lower boundary of the tumor is 10 cm from the anus≤); * The patient consents to participate in the clinical study and signs the informed consent form. Exclusion Criteria: * Patients with significant local or systemic severe infection; * Acute abdomen: intestinal obstruction, peritonitis, intestinal perforation; * Have a systemic underlying disease that has not been controlled, or is unstable; Patients with poor constitution or serious other organic diseases who cannot tolerate anesthesia and surgery; * Women during pregnancy, perinatal and lactation; * Patients who are mentally incapable or unable to understand the requirements of the study; * Patients who participated in other clinical studies 6 weeks before the start of this study or at the same time; * The life expectancy of patients with malignant tumors is less than 6 months; * Those who are critically ill and find it difficult to make an accurate evaluation of the effectiveness and safety of the device; * Patients with diseases who are believed not suitable to participate in this clinical study; * Have other diseases that are against anastomosis; * The patient is receiving hormone therapy or immunosuppressive therapy; * Albumin\< 30g/dl.
References
Publications (0)
Data not yet available