The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload (2.0mm, 2.5mm, 3.25mm, 4.0mm, 5.0mm and 5.5mm).
Gijos Clinic
Kaunas, Lithuania
RECRUITINGPost Operative Staple Line Complications
The primary measure of effectiveness and safety will be determined by the incidence of post-operative staple line complications defined as requiring blood transfusion and revision surgery to treat staple line complications.
Time frame: 1 week
Hospital Stay
Average hospital stay will be measure and compared in patients without post-operative staple line complications vs. patients with post-operative staple line complications.
Time frame: 1 week
36-Item Short Form Health Survey (SF-36)
SF-36 scores will be collected at baseline and at the 3-week follow up appointment and compared for quality-of-life changes.
Time frame: 3 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.