N/A
Completed N=30
Intrathoracic Esophagogastric Anastomosis After Robot Assisted Minimally Invasive Esophagectomy Using STRATAFIX
Source: ClinicalTrials.gov NCT02609425 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Anastomotic Leak Rate After Esophagectomy
Summary
Determine the safety and efficacy of novel suture in esophageal anastomosis. Specific Aims: 1) Determine the safety of using STRATAFIX suture in esophagogastric anastomosis by measuring anastomotic leak rate; and 2) Determine efficacy of STRATAFIX suture in esophagogastric anastomosis by measure anastomotic stricture rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anastomotic Leak Rate After Esophagectomy |
— | — |
| SECONDARY Anastomotic Stricture Rate After Esophagectomy |
— | — |
Eligibility Criteria
Inclusion Criteria
- All patients with esophageal cancer who are deemed candidates for minimally invasive robot assisted Ivor Lewis esophagogastrostomy.
- Patients who provide written informed consent for the study.
Exclusion Criteria
- Any patient with esophageal cancer who is not deemed a surgical candidate or who is not deemed a candidate for the Ivor Lewis technique of esophagectomy (with intrathoracic anastomosis).
- Any patient less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT02609425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.