CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery

Colorectal Cancer Clinical Trial

— CAIRECTAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175756
• Other study ID #: AAG-O-H-1627
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: July 2021
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 28, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• Caiman 5 articulating Maryland
Laparoscopic colorectal surgery

Locations

Country	Name	City	State
Germany	Alfried Krupp Krankenhaus Rüttenscheid	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total operative time	Time between first incision and closure of the surgical incision	intraoperatively
Secondary	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
Secondary	Handling characteristics	Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)	intraoperative
Secondary	Estimated intraoperative blood loss	intraoperative blood loss in ml	intraoperative
Secondary	Time needed for TME	Time between end of left flexure mobilization and stapling	Intraoperative
Secondary	Time needed for PME	Time [in minutes] between end of left flexure mobilization and stapling	Intraoperative
Secondary	Time needed for CME	Time [in minutes] between end of ileocolic vessels clipping and start of right flexure mobilization	Intraoperative
Secondary	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
Secondary	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
Secondary	Stay in intensive care unit postop	Number of days postoperative until discharge from intensive care unit	up to discharge (approximately 10 days postoperative)
Secondary	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)
Secondary	First postoperative oral intake	Number of days until patient's first postoperative oral intake	up to discharge (approximately 10 days postoperative)
Secondary	First postoperative stool	Number of days until patient's first postoperative stool after oral intake	up to discharge (approximately 10 days postoperative)
Secondary	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)