The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
Study Type
OBSERVATIONAL
Surgical intervention with the FMwand Surgical System
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System
Time frame: 1 day after surgery
Post-operative Drainage
Volume of drainage and drain residence time
Time frame: Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
Onset of urinary or fecal incontinence
Incidence of urinary or fecal incontinence attributed to post-surgical nerve dysfunction
Time frame: Beginning day 2 after surgery and for the duration of the hospital stay, an expected average of 6 days
Duration of Procedure
Total operative time
Time frame: During Procedure
Duration of TME resection
Total resection time
Time frame: During procedure
Evaluation of post-operative complications
Evaluation of pelvic fibrosis, adherences, abscess or fluid collections assessed by CT scan
Time frame: 12 weeks after surgery
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