N/A
N=168
A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Left-sided Colon Resection
Bottom Line
View on ClinicalTrials.gov: NCT03326895 ↗Enrolled (actual)
168
Serious AEs
7.7%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Participants With Stapler Performance Issues — 11.9 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Left-sided colon resection (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Stapler Performance Issues |
11.9 | — |
| SECONDARY SURG-TLX Questionnaire |
38.0; 44.9; 37.9; 30.3; 50.3; 38.6 | — |
Summary
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
Eligibility Criteria
Inclusion Criteria
- Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler;
- Willing to give consent and comply with all study-related evaluations; and
- At least 18 years of age.
Exclusion Criteria
- Enrollment in a concurrent clinical study;
- Pregnancy;
- Physical or psychological condition which would impair study participation;
- Emergency surgery;
- ASA Class ≥ IV;
- The subject is judged unsuitable for study participation by the Investigator; or
- Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections;
- Anastomosis not distal from splenic flexure of the colon 10. Anastomosis of the colon not attempted 11. Subjects with any intraoperative findings identified by the surgeon that would preclude attempting an anastomosis with a circular stapler.
Data sourced from ClinicalTrials.gov (NCT03326895). 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.