This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.
Study Type
OBSERVATIONAL
Enrollment
61
Laparoscopic colorectal surgery
Alfried Krupp Krankenhaus Rüttenscheid
Essen, Germany
Total operative time
Time between first incision and closure of the surgical incision
Time frame: intraoperatively
Complications
Number of Complications: Wound infections, Urinary tract infections, Pulmonary infections, Other infections, Wound dehiscence, Anastomotic leak, Anastomotic bleeding, Other bleeding / hemorrhage, Intraabdominal abscess, Fistula, Peritonitis, Sepsis, Hernia, Stenosis Ileus, Ureter injury, Nerve injury, Cardiac complications, Other
Time frame: up to 4 months postoperative
Handling characteristics
Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
Time frame: intraoperative
Estimated intraoperative blood loss
intraoperative blood loss in ml
Time frame: intraoperative
Time needed for TME
Time between end of left flexure mobilization and stapling
Time frame: Intraoperative
Time needed for PME
Time \[in minutes\] between end of left flexure mobilization and stapling
Time frame: Intraoperative
Time needed for CME
Time \[in minutes\] between end of ileocolic vessels clipping and start of right flexure mobilization
Time frame: Intraoperative
Time needed for right / hepatic colic flexure mobilization
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Time \[in minutes\] between end CME and start of resection of the mesentery of the small intestine
Time frame: Intraoperative
Time needed for left / splenic colic flexure mobilization
Time \[in minutes\] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)
Time frame: Intraoperative
Stay in intensive care unit postop
Number of days postoperative until discharge from intensive care unit
Time frame: up to discharge (approximately 10 days postoperative)
Stay in intermediate care unit stay postop
Number of days postoperative until discharge from intermediate care unit stay
Time frame: up to discharge (approximately 10 days postoperative)
First postoperative oral intake
Number of days until patient's first postoperative oral intake
Time frame: up to discharge (approximately 10 days postoperative)
First postoperative stool
Number of days until patient's first postoperative stool after oral intake
Time frame: up to discharge (approximately 10 days postoperative)
Quality of excision: M.E.R.C.U.R.Y. criteria
quality of mesorectal excision according to criteria established in the "Magnetic Resonance Imaging and Rectal Cancer European Equivalence Study" (M.E.R.C.U.R.Y.)
Time frame: up to discharge (approximately 10 days postoperative)