CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Caiman 5 articulating Maryland


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Caiman 5 articulating Maryland|Laparoscopic colorectal surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total operative time | Time between first incision and closure of the surgical incision | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | intraoperative | 
| Estimated intraoperative blood loss | intraoperative blood loss in ml | intraoperative | 
| Time needed for TME | Time between end of left flexure mobilization and stapling | Intraoperative | 
| Time needed for PME | Time [in minutes] between end of left flexure mobilization and stapling | Intraoperative | 
| Time needed for CME | Time [in minutes] between end of ileocolic vessels clipping and start of right flexure mobilization | Intraoperative | 
| Time needed for right / hepatic colic flexure mobilization | Time [in minutes] between end CME and start of resection of the mesentery of the small intestine | 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) | Intraoperative | 
| Stay in intensive care unit postop | Number of days postoperative until discharge from intensive care unit | 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 | up to discharge (approximately 10 days postoperative) | 
| First postoperative oral intake | Number of days until patient's first postoperative oral intake | up to discharge (approximately 10 days postoperative) | 
| First postoperative stool | Number of days until patient's first postoperative stool after oral intake | 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.) | up to discharge (approximately 10 days postoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, laparoscopic surgery, Seal & Cut, Total Mesorectal Excision (TME), Partial Mesorectal Excision (PME), Complete Mesocolic Excision (CME)