CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT04175756
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2020-01-02
• Primary Completion: 2021-01-10
• Study Completion: 2021-04-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total operative time	intraoperatively	Time between first incision and closure of the surgical incision

Secondary Outcome Measures

Name	Time	Method
Estimated intraoperative blood loss	intraoperative	intraoperative blood loss in ml
Time needed for CME	Intraoperative	Time \[in minutes\] between end of ileocolic vessels clipping and start of right flexure mobilization
Time needed for TME	Intraoperative	Time between end of left flexure mobilization and stapling
First postoperative stool	up to discharge (approximately 10 days postoperative)	Number of days until patient's first postoperative stool after oral intake
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
Time needed for PME	Intraoperative	Time \[in minutes\] between end of left flexure mobilization and stapling
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
Handling characteristics	intraoperative	Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)
First postoperative oral intake	up to discharge (approximately 10 days postoperative)	Number of days until patient's first postoperative oral intake
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)
Stay in intensive care unit postop	up to discharge (approximately 10 days postoperative)	Number of days postoperative until discharge from intensive care unit
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.)
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

Trial Locations

Locations (1)

Alfried Krupp Krankenhaus Rüttenscheid; 🇩🇪 Essen, Germany