Colorectal Cancer
Conditions
Keywords
colorectal cancer, laparoscopic surgery, Seal & Cut, Total Mesorectal Excision (TME), Partial Mesorectal Excision (PME), Complete Mesocolic Excision (CME)
Brief summary
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.
Interventions
DEVICECaiman 5 articulating Maryland
Laparoscopic colorectal surgery
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient´s written informed consent * Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU) * Age ≥18 years
Exclusion criteria
* Emergency surgery * Pregnancy * Participation in another surgical study, which might influence the intraoperative process * Conversion to open surgery * Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time | intraoperatively | Time between first incision and closure of the surgical incision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handling characteristics | intraoperative | Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor) |
| Estimated intraoperative blood loss | intraoperative | intraoperative blood loss in ml |
| Time needed for TME | Intraoperative | Time between end of left flexure mobilization and stapling |
| Time needed for PME | Intraoperative | Time \[in minutes\] between end of left flexure mobilization and stapling |
| Time needed for CME | Intraoperative | Time \[in minutes\] between end of ileocolic vessels clipping and start of right flexure mobilization |
| Time needed for right / hepatic colic flexure mobilization | Intraoperative | Time \[in minutes\] between end CME and start of resection of the mesentery of the small intestine |
| Complications | up to 4 months postoperative | 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 |
| Stay in intensive care unit postop | up to discharge (approximately 10 days postoperative) | Number of days postoperative until discharge from intensive care unit |
| Stay in intermediate care unit stay postop | up to discharge (approximately 10 days postoperative) | Number of days postoperative until discharge from intermediate care unit stay |
| First postoperative oral intake | up to discharge (approximately 10 days postoperative) | Number of days until patient's first postoperative oral intake |
| First postoperative stool | up to discharge (approximately 10 days postoperative) | Number of days until patient's first postoperative stool after oral intake |
| Quality of excision: M.E.R.C.U.R.Y. criteria | up to discharge (approximately 10 days postoperative) | 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 needed for left / splenic colic flexure mobilization | Intraoperative | Time \[in minutes\] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding) |
Countries
Germany
Outcome results
None listed